handbook of capsule endoscopy

Handbook of Capsule Endoscopy

Zhaoshen Li · Zhuan Liao Mark McAlindon Editors

123

Handbook of Capsule Endoscopy

Zhaoshen Li • Zhuan LiaoMark McAlindonEditors

Handbook of CapsuleEndoscopy

123

EditorsZhaoshen LiZhuan LiaoDepartment of GastroenterologyChanghai HospitalShanghaiChina

Mark McAlindonGastroenterologyRoyal Hallamshire HospitalSheffieldUK

ISBN 978-94-017-9228-8 ISBN 978-94-017-9229-5 (eBook)DOI 10.1007/978-94-017-9229-5Springer Dordrecht Heidelberg New York London

Library of Congress Control Number: 2014943402

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Contents

1 The History of Wireless Capsule Endoscopy:From a Dream to a Platform of Capsules . . . . . . . . . . . . . 1Rami EliakimReferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 The Current Main Types of Capsule Endoscopy . . . . . . . . 5Zhaoshen Li, Dan Carter, Rami Eliakim, Wenbin Zou,Hao Wu, Zhuan Liao, Zhaotao Gong, Jinshan Wang,Joo Won Chung, Si Young Song, Guohua Xiao,Xiaodong Duan and Xinhong Wang2.1 The Given Imaging Capsule Endoscopy Platform:

Clinical Use in the Investigation of Small Bowel,Esophageal and Colonic Diseases . . . . . . . . . . . . . . . . 5

2.2 EndoCapsule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162.3 OMOM Capsule Endoscopy Platform . . . . . . . . . . . . . 182.4 MiroCam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242.5 The Ankon Magnetic-Controlled Capsule Endoscopy

Platform in the Clinical Investigation of StomachDiseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.6 CapsoCam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

3 Small Bowel Capsule Endoscopy . . . . . . . . . . . . . . . . . . . . 47Imdadur Rahman, Praful Patel, Emanuele Rondonotti,Anastasios Koulaouzidis, Marco Pennazio, Rahul Kalla,Reena Sidhu, Peter Mooney, David Sanders,Edward J. Despott, Chris Fraser, Niehls Kurniawan,Peter Baltes, Martin Keuchel, Carolyn Davison,Nigel Beejay, Clare Parker and Simon Panter3.1 Preparation for Small Bowel Capsule Endoscopy . . . . . 483.2 Obscure Gastrointestinal Bleeding . . . . . . . . . . . . . . . 523.3 The Use of Capsule Endoscopy for Small Bowel

Crohn’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . 613.4 Capsule Endoscopy in Coeliac Disease . . . . . . . . . . . . 663.5 Polyposis Syndromes . . . . . . . . . . . . . . . . . . . . . . . . 76

v

3.6 Less Common Indications for Small BowelCapsule Endoscopy. . . . . . . . . . . . . . . . . . . . . . . . . . 80

3.7 Optimising Safety in Small Bowel CapsuleEndoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

4 Oesophageal Capsule Endoscopy . . . . . . . . . . . . . . . . . . . . 119Anastasios Koulaouzidis, Sarah Douglas and John N. Plevris4.1 Oesophageal Capsule . . . . . . . . . . . . . . . . . . . . . . . . 1194.2 Ingestion Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . 1204.3 Clinical Use of Oesophageal Capsule Endoscopy . . . . . 1214.4 Oesophageal Varices Screening . . . . . . . . . . . . . . . . . 1234.5 Contraindications and Complications . . . . . . . . . . . . . 1244.6 Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1254.7 Specialised Groups . . . . . . . . . . . . . . . . . . . . . . . . . . 1254.8 Capsule Options for the Future. . . . . . . . . . . . . . . . . . 125References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

5 Colon Capsule Endoscopy . . . . . . . . . . . . . . . . . . . . . . . . . 129Cristiano Spada and Samuel Adler5.1 Regimen of Preparation and Procedure . . . . . . . . . . . . 1295.2 Indications and Contraindications . . . . . . . . . . . . . . . . 1315.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1335.4 Safety and Feasibility . . . . . . . . . . . . . . . . . . . . . . . . 1345.5 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6 Non-imaging Capsule Endoscopy: The Wireless MotilityCapsule to Assess Gut Motility . . . . . . . . . . . . . . . . . . . . . 137Anton Emmanuel6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1376.2 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1376.3 Measurement Parameters . . . . . . . . . . . . . . . . . . . . . . 1386.4 Clinical Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1386.5 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1416.6 Clinical Applications of the WMC . . . . . . . . . . . . . . . 1416.7 Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1426.8 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

7 Capsule Endoscopy in Pediatrics . . . . . . . . . . . . . . . . . . . . 145Salvatore Oliva and Stanley Cohen7.1 Small Bowel Capsule Endoscopy in Pediatrics . . . . . . . 1457.2 The Esophageal Capsule in Pediatric Patients . . . . . . . 1487.3 The Colon Capsule in Pediatric Patients . . . . . . . . . . . 149References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

vi Contents

8 Comparison of Capsule Endoscopy and Device-AssistedEnteroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Sung Chul Park and Hoon Jai Chun8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1538.2 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

9 Future Development of Capsule Endoscopy . . . . . . . . . . . . 165Melissa F. Hale and Mark McAlindon9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1659.2 Technical Improvements . . . . . . . . . . . . . . . . . . . . . . 1659.3 Novel Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . 1669.4 Novel Directions . . . . . . . . . . . . . . . . . . . . . . . . . . . 1679.5 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

10 Case Presentations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Zhuan Liao, Min Tang, Qiang Guo, Bangmao Wang,Qiong He, Fachao Zhi, Mark McAlindon, Dan Carter,Rami Eliakim, Anastasios Koulaouzidis, Sarah Douglas,Wenbin Zou, Zhizheng Ge and Zhaoshen Li10.1 Small Bowel Capsule Endoscopy I . . . . . . . . . . . . . . . 17110.2 Small Bowel Capsule Endoscopy II . . . . . . . . . . . . . . 17610.3 Small Bowel Capsule Endoscopy III . . . . . . . . . . . . . . 18110.4 Small Bowel Capsule Endoscopy IV. . . . . . . . . . . . . . 18610.5 Small Bowel Capsule Endoscopy V . . . . . . . . . . . . . . 18710.6 Esophageal Capsule Endoscopy . . . . . . . . . . . . . . . . . 19010.7 Gastric Capsule Endoscopy . . . . . . . . . . . . . . . . . . . . 19310.8 Colon Capsule Endoscopy . . . . . . . . . . . . . . . . . . . . . 195

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Contents vii

Contributors

Samuel Adler Department of Gastroenterology, Shaare Zedek MedicalCenter, Jerusalem, Israel

Peter Baltes Clinic for Internal Medicine, Bethesda Hospital Bergedorf,Hamburg, Germany

Nigel Beejay Institute of Medicine, Sheikh Khalifa Medical City Hospital,Abu Dhabi, United Arab Emirates. London Independent Hospital, London,UK

Dan Carter Department of Gastroenterology, Sheba Medical Center, Sac-kler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

Hoon Jai Chun Division of Gastroenterology and Hepatology, Departmentof Internal Medicine, Korea University Anam Hospital, Korea UniversityCollege of Medicine, Seongbuk-Gu, Seoul, South Korea

Joo Won Chung Division of Gastroenterology, Department of InternalMedicine, National Medical Center, 245 Euljiro, Jung-gu, Seoul 100-799,Korea

Stanley Cohen Children’s Center for Digestive Health Care, Atlanta, GA,USA

Carolyn Davison South Tyneside NHS Foundation Trust, Tyne and Wear,UK

Edward J. Despott Royal Free Unit for Endoscopy, Royal Free Hospital,University College London, Institute for Liver and Digestive Health, Lon-don, UK

Sarah Douglas The Royal Infirmary of Edinburgh, Centre for Liver andDigestive Disorders, Edinburgh, UK

Xiaodong Duan Department of Gastroenterology, Changhai Hospital,Second Military Medical University, Yangpu District, Shanghai, China

Rami Eliakim Department of Gastroenterology, Sheba Medical Center,Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

Anton Emmanuel GI Physiology Unit, University College London, Lon-don, UK

ix

Chris Fraser Wolfson Unit for Endoscopy, St Mark’s Hospital and Aca-demic Institute, Imperial College London, London, UK

Zhaotao Gong Chongqing Jinshan Science and Technology Co., Ltd.,Chongqing, China

Qiang Guo Department of Gastroenterology, The First People’s Hospital ofYunnan Province, Kunming, China

Melissa F. Hale Directorate of Gastroenterology, Royal Hallamshire Hos-pital, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK

Qiong He Department of Gastroenterology, The Third Affiliated Hospital ofSouthern Medical University, Guangzhou, ChinaDepartment of Gastroen-terology, Nanfang Hospital, Southern Medical University, Guangzhou,China

Rahul Kalla Gastrointestinal Unit, Institute of Genetics and MolecularMedicine, University of Edinburgh, Edinburgh, England

Martin Keuchel Clinic for Internal Medicine, Bethesda Hospital Bergedorf,Hamburg, Germany

Anastasios Koulaouzidis The Royal Infirmary of Edinburgh, Centre forLiver and Digestive Disorders, Edinburgh, Scotland, UK

Niehls Kurniawan Clinic for Internal Medicine, Bethesda HospitalBergedorf, Hamburg, Germany

Zhaoshen Li Department of Gastroenterology, Changhai Hospital, SecondMilitary Medical University, Yangpu District, Shanghai, China

Zhuan Liao Department of Gastroenterology, Changhai Hospital, SecondMilitary Medical University, Yangpu District, Shanghai, China

Mark McAlindon Directorate of Gastroenterology, Royal HallamshireHospital, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK

Peter Mooney Directorate of Gastroenterology, Royal Hallamshire Hospi-tal, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK

Salvatore Oliva Pediatric Gastroenterology and Liver Unit, SapienzaUniversity of Rome, Rome, Italy

Simon Panter South Tyneside NHS Foundation Trust, Tyne and Wear, UK

Sung Chul Park Division of Gastroenterology and Hepatology, Departmentof Internal Medicine, Kangwon National University Hospital, KangwonNational University School of Medicine, Chuncheon, Kangwon-do, SouthKorea

Clare Parker South Tyneside NHS Foundation Trust, Tyne and Wear, UK

Praful Patel Gastrointestinal Department, University Hospital SouthamptonFoundation Trust, Southampton, UK

x Contributors

Marco Pennazio 2nd Division of Gastroenterology, Department of Medi-cine, San Giovanni Battista University Teaching Hospital, Torino, Italy

John N. Plevris Centre for Liver and Digestive Disorders, The RoyalInfirmary of Edinburgh, Edinburgh, Scotland

Imdadur Rahman Gastrointestinal Department, University HospitalSouthampton Foundation Trust, Southampton, UK

Emanuele Rondonotti Ospedale Valduce, Gastroenterology Unit, Como,Italy

David Sanders Directorate of Gastroenterology, Royal Hallamshire Hos-pital, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK

Reena Sidhu Gastroenterology and Liver Unit, Royal Hallamshire Hospi-tal, Sheffield Teaching Hospitals NHS Trust, University of Sheffield,Sheffield, England

Si Young Song Division of Gastroenterology, Department of InternalMedicine, Yonsei University College of Medicine, Brain Korea 21 Projectfor Medical Science, 250 Seongsanno, Seodaemun-gu, Seoul, Korea

Cristiano Spada Digestive Endoscopy Unit, Catholic University, Rome,Italy

Min Tang Department of Gastroenterology, The First People’s Hospital ofYunnan Province, Kunming, China

Bangmao Wang Department of Gastroenterology, General Hospital Affil-iated to Tianjin Medical University, Tianjin, China

Jinshan Wang Chongqing Jinshan Science and Technology Co., Ltd.,Chongqing, China

Xinhong Wang Department of Gastroenterology, Changhai Hospital, Sec-ond Military Medical University, Yangpu District, Shanghai, China

Hao Wu Department of Gastroenterology, Changhai Hospital, SecondMilitary Medical University, Yangpu District, Shanghai, China

Guohua Xiao Department of Gastroenterology, Changhai Hospital, SecondMilitary Medical University, Yangpu District, Shanghai, China

Fachao Zhi Department of Gastroenterology, Nanfang Hospital, SouthernMedical University, Guangzhou, China

Zhizheng Ge Department of Gastroenterology and Hepatology, DigestiveEndoscopy Centre, Renji Hospital, School of Medicine, Shanghai Jiao TongUniversity, Shanghai, China

Wenbin Zou Department of Gastroenterology, Changhai Hospital, SecondMilitary Medical University, Yangpu District, Shanghai, China

Contributors xi

1The History of Wireless CapsuleEndoscopy: From a Dream to a Platformof Capsules

Rami Eliakim

Direct visualization of the gastrointestinal tractby traditional endoscopy was introduced anddeveloped over the last 50 years or so. Fairlyfast gastroenterologists moved from rigid eso-phago-gastroscopes to flexible scopes and tohigh-definition videoscopes, daily used for theupper and lower GI endoscopies as well as forthe biliary tract. The small intestine posed aproblem as no direct visualization of its wholecourse was available, push enteroscopy allowingvisualization of about 50 % of its length.

In the early 1980s, 1981 to be exact, twoIsraelis, an electro-optical engineer, Gabi Iddan,on sabbatical from Rafael Ltd and a gastroen-terologist, Eitan Scapa, also on sabbatical, livingin the same neighborhood in Boston, met anddiscussed their respective fields of work andinterest. Through this neighborly chat, Iddanlearned what gastroenterology was all about,about fiber-optic endoscopes, their use as well aslimitations, one of which was their inaccessi-bility to visualize most of the small intestine. Itwas Scapa that challenged Iddan into finding amethod to view the entire small bowel. The ideawas there, but there were no good solutions noradvanced technology.

The two became friends, and 10 years later,in 1991, Scapa visited Iddan who was again onsabbatical and rechallenged him with the sameproblem. By that period of time, small-formatimage sensors (CCD) were developed (for usagein video cameras) and were starting to be used inthe new-generation endoscopes replacing thefiberscope method.

This led Gabi to think of cutting the cameratip of the endoscope and letting it move natu-rally through threw GI tract, connected to theendoscope via a thin ‘‘umbilical’’ cable. Thisidea was dropped very fast, knowing the actuallength of the small bowel.

The next step/thought was to replace thecable with a transmitter. This idea of a trans-mitter-equipped camera was continuouslydeveloped. Apart from the apparatus itself, otherbasic questions arose: How would the cameralens be kept clean? How long will it take for it tomove through the small bowel and will thephysician be available for like 8 h? Will theexisting miniature batteries operate for longerthan 10–15 min, without taking into account theenergy needed for transmission and for illumi-nation. These overwhelming challenges almostcaused Iddan to abandon the project. Then, hedecided to tackle each obstacle at a time.

His first assumption regarded the shape of thecamera’s optic dome; he fabricated an axiconoptic window assuming this shape will contin-uously be cleaned while moving. He added aminiature CCD and a light source and experi-mentally showed that this produced reasonable

R. Eliakim (&)Department of Gastroenterology, Chaim ShebaMedical Center, 2nd Sheba Road, 52621Ramat-Gan, Israele-mail: [email protected]

Z. Li et al. (eds.), Handbook of Capsule Endoscopy,DOI: 10.1007/978-94-017-9229-5_1, � Springer Science+Business Media Dordrecht 2014

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images. Some of these first models are shown inFig. 1.1.

One of the first experiments Iddan recalls wasusing a store-bought chicken to test and under-stand what power and frequency required fortransmission from the GI tract. They learned thatwith proper tuning of the frequency, microwattlevel of power was needed to transmit clearvideo images, which was very encouraging.

A big step forward was done a year later, in1993, when a new-generation CCD imager wasdeveloped and reported on [1], requiring muchless energy than the old ones. Another break-through, though conceptual, was to separate thedevice into 3 parts: an imager + transmitter,recorder, and a workstation, a solution that willenable the physician to interpret the resultsindependently from the workstation, withoutconstant real-time viewing. A multiple antennaarray system was added to guarantee properreception and was the basis of the later-on-incorporated localization system. In 1995, Iddanpresented his idea to Gavriel Meron, at the timethe CEO of Applitec Ltd., a company develop-ing small cameras for fiberscopes. In 1997, anew start-up company headed by Meron and

Iddan (Given Imaging) was initiated. By thattime, they were aware of the development of thecomplementary metal oxide semiconductorimaging (CMOS camera) that allowed good-quality images with substantially less energythan the CCD, crucial for the development of acapsule endoscope.

Practically at the same time, as early as 1981,another group of researchers led by a gastroen-terologist, Paul Swain, and his colleagues wereworking on laser devices and radio frequency totreat bleeding in the GI tract. Later on, theydeveloped a wireless pH capsule which wassewn to the stomach wall and started to use thattechnology. In the early 1990s, they started toexplore wireless technology for endoscopy andacquired tiny video cameras and transmittersfrom various sources including security camerasand sport video equipment firms.

In 1994, Paul Swain brought up the possi-bility of a wireless endoscope in a lecture givenduring the world congress of gastroenterology.Later on, in 1966, Swain’s group started testingtransmission of video images through the humanbody, when they surgically inserted a largeprototype device with video camera and

Fig. 1.1 Historicalprototypes of the capsule.Reprint with permissionfrom Gastrointest EndoscClin N Am [2]

2 R. Eliakim

microwave transmission, a light source, and abattery into a pig stomach. This allowedacquiring images at 30 frames per second forabout 20 min.

In 1997, the two groups met for the first time,and in 1998, the groups agreed to collaborate.Experiments with working prototypes wereconducted in the beginning of 1999 in Israel,followed by the first human experiment ofswallowing a 11 9 33 mm capsule by PaulSwain in Eitan Scapa’s private clinic, the batteryof which lasted for 2 h. Gastroscopy was done tosure the capsule has passed the pylorus. Swainswallowed a second capsule the next day in hishotel room which transmitted good-qualityimages for 6 h in which the capsule reached thececum.

The initial findings were presented in Diges-tive Disease Week in 2000, the first patient trialwas initiated, the invention was published inNature [3], and FDA approve that same year.

Since then a platform of capsules was intro-duced by Given Imaging including a second andthird generation of small bowel capsules (PillCamSB3) in which the light source, battery time, angleof view, and frame rates per second wereimproved, two generations of a two-sided esoph-ageal capsule (PillCam Eso2), two generations ofcolon capsule (PillCam Colon2) with adaptedframe rate and a much wider angle of view, andtwo generations of a patency capsule (Agile)allowing to test whether a regular capsule will passwere developed (Fig. 1.2). Human studies on anupper GImagnetic capsule have been published by

Fig. 1.2 Time line of thedevelopment of thedifferent capsules in thegiven platform

Fig. 1.3 Various smallbowel capsule endoscopesin use

1 The history of wireless capsule endoscopy 3

both Given Imaging and Olympus, and there aremany self-propelling capsules that are beingdeveloped and tested in animals. Moreover, com-petitive small bowel capsules have been manu-factured by Korean, Japanese, Chinese, andAmerican companies (Fig. 1.3). Small bowl cap-sule endoscopy is in routine use all over the globefor many indications—a dream come true.

References

1. Fossum ER. Active image sensors: are CCDs dino-saurs? Int Soc Opt Eng (SPIE). 1993;1900:2–14.

2. Iddan GV, Swain P. History and development ofcapsule endoscopy. Gastrointest Endosc Clin N Am.2004;14:1–9.

3. Iddan G, Meron G, Glukhovsky A, Swain P. Wirelesscapsule endoscopy. Nature. 2000;405:417.

4 R. Eliakim

2The Current Main Types of CapsuleEndoscopy

Zhaoshen Li, Dan Carter, Rami Eliakim,Wenbin Zou, Hao Wu, Zhuan Liao, Zhaotao Gong,Jinshan Wang, Joo Won Chung, Si Young Song,Guohua Xiao, Xiaodong Duan and Xinhong Wang

2.1 The Given Imaging CapsuleEndoscopy Platform: ClinicalUse in the Investigationof Small Bowel, Esophagealand Colonic Diseases

2.1.1 Introduction

The first video capsule endoscope was introducedin 2001 by Iddan as a new tool for the investiga-tion of the small bowel [1]. Initially called mouthto anus (M2A), its goal was small bowel visuali-zation. Since then, various studies have shown thepotential of this minimally invasive technique toimprove diagnostic outcomes among a variety ofgastrointestinal (GI) conditions. Later on, theesophageal and colonic capsules [2, 3] werelaunched into the market, and the patency capsulewas introduced as well. The introduction of thesecond or even third generation of capsulesenabled broadening the horizon for its possiblemedical use (Fig. 2.1, Table 2.1). To date, mul-tiple capsule endoscopy (CE) systems are avail-able (Fig. 2.2), mostly for the small bowel. Asmentioned, the first capsule endoscopy systemwas manufactured by Given Imaging (Yokneam,Israel). To date, the Given Imaging platform ofcapsule endoscopes includes the PillCamSB2 andSB3 for the small intestine, the PillCam ESO2 foresophageal imaging, PillCamColon2 for the large

Z. Li (&) � W. Zou (&) � H. Wu � Z. Liao (&) �G. Xiao X. Duan � X. WangDepartment of Gastroenterology, ChanghaiHospital, Second Military Medical University, 168Changhai Road, Yangpu District, Shanghai, 200433Chinae-mail: [email protected]

W. Zoue-mail: [email protected]

Z. Liaoe-mail: [email protected]

D. CarterDepartment of Gastroenterology, Chaim ShebaMedical Center, 2nd Sheba Road, 52621Ramat-Gan, Israele-mail: [email protected]

Z. T. Gong � J. S. WangChongqing Jinshan Science and Technology Co.,Ltd., Chongqing, China

J. W. ChungDivision of Gastroenterology, Department ofInternal Medicine, National Medical Center, 245Euljiro, Jung-gu, Seoul, 100-799 Koreae-mail: [email protected]

S. Y. Song (&)Division of Gastroenterology, Department ofInternal Medicine, Yonsei University College ofMedicine, Brain Korea 21 Project for MedicalScience, 250 Seongsanno, Seodaemun-gu, Seoul,Koreae-mail: [email protected]

R. Eliakim (&)Head Department of Gastroenterology, ChaimSheba Medical Center, 2nd Sheba Road, 52621Ramat-Gan, Israele-mail: [email protected]

Z. Li et al. (eds.), Handbook of Capsule Endoscopy,DOI: 10.1007/978-94-017-9229-5_2, � Springer Science+Business Media Dordrecht 2014

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bowel, as well as the Agile Patency capsule(second generation) (Fig. 2.3). Additional smallbowel capsule systems include the Olympus En-doCapsule (Olympus, Japan) [4], the ChineseOMOM pill (Jinshan science and technology,Chongqing, China) [5], the Korean Miro pill [6],

and the American CapsoCam SV-1. Comparativestudies between the PillCam SB1 and the Olym-pus EndoCapsule or the KoreanMiro Capsule didnot show significant differences. Currently, onlythe Given PillCam SB system and the OlympusEndoCapsule are FDA- and CE-approved.

Fig. 2.1 PillCam smallbowel 3 capsule endoscopesystem

6 Z. Li et al.

The PillCam SB3 video capsule endoscopysystem consists of (a) a 2 9 11 mm capsulecontaining the video camera, illumination, andbatteries; (b) a sensing system comprising anarray of sensor pads, a data recorder, and abattery pack; and (c) a workstation, based on acommercially available personal computer(Fig. 2.1). The new data recorders (DR3) alsocontain a portable real-time viewer that allowsdirect monitoring of the images received during

Table 2.1 Indications for the use of capsule endoscopyaccording to anatomic site

Esophagus

Gastroesophageal reflux disease

Barrett’s esophagus

Esophageal varices

Small Bowel

Obscure gastrointestinal bleeding

Suspected Crohn’s disease

Suspected small bowel tumor

Evaluation of any abnormal small bowel imaging

Evaluation of partially responsive celiac disease

Surveillance of inherited polyposis syndromes

Evaluation of drug-induced small bowel injury

Evaluation of mucosal response to medications

Colon

Polyp screening

Fig. 2.2 Various systems of capsule endoscopes available for the small bowel

Fig. 2.3 The Agile patency capsule system

2 The Current Main Types of Capsule Endoscopy 7

the examination. While the PillCam capturesimages using a complementary metal-oxidesemiconductor (CMOS) sensor, the EndoCap-sule, MiroCam, and OMOM capsule use acharge-coupled device camera (CCD). The fourcapsules also differ with regard to dimensions,image acquisition frame rate, field of view, andrecording duration.Almost all of the information provided in theliterature is regarding the Given Imaging Pill-Cam SB, as it dominated the market for a fewyears by itself, later on joined by the other smallbowel capsules, and thus is the one on whichmost of the literature is written.

2.1.2 Small Bowel Video CapsuleEndoscopy

Until the introduction of the small bowel videocapsule endoscopy (SBCE), the small bowel wasan organ that was very difficult to explore with theavailable techniques. Since its development,SBCE provided a reliable, noninvasive, and well-accepted and well-tolerated procedure, which hasrevolutionized the study of the small bowel.

PillCam SB3 video capsule endoscope is awireless capsule (11 9 26 mm) comprised of alight source, lens, CMOS imager, battery, and awireless transmitter. A slippery coating allowseasy ingestion and prevents adhesion of bowelcontents, as it moves via peristalsis from themouth to the anus (Figs. 2.1, 2.4). The batteryprovides [11 h of work in which the capsulephotographs using an adaptive frame rate tech-nique two to six images per second ([80,000images all together), in a 156� field of view and8:1 magnification. The pictures are transmittedvia a newly developed ‘no attachments’ sensorbelt, to a small data recorder (DR3) which alsoallows real-time imaging. The recorder isdownloaded into a Reporting and Processing ofImages and Data computer workstation (RAPID8) and seen as a continuous video film. Supportsystems have been added since the first prototypeof the RAPID system, including a localizationsystem, a blood detector, a double and quadric

picture viewer, a ‘quick viewer,’ single pictureadjustment mode, incorporation of the FujiIntelligent Color Enhancement (FICE) system,an inflammation (Lewis) scoring system, and anatlas, all meant to assist the interpreter.

The procedure: The patient is on clear liq-uids the day prior to the procedure and swallowsthe capsule with water after a 12-h fast. Drinkingclear fluids is allowed 2 h after ingestion as is alight lunch after 4 h. During the procedure, he isfree to do his daily activities.

Fig. 2.4 Small bowel pictures taken with PillCam SB3:a Ampulla of Vater. b Small bowel normal mucosa

8 Z. Li et al.

A few grading scales have been developed toassess the quality of bowel preparation in videocapsule endoscopy, the most recent being acomputer-assisted cleansing score (CAC) [7].The impact of bowel preparation on the imagequality and transit time was assessed in twometa-analyses. Preparation was found toimprove the quality of visualization, but had noeffect on transit times or percentage of capsulesreaching the cecum, and no consensus wasreached as to the effects on the diagnostic yieldof the study [8, 9]. Another attempt to improvethe small bowel diagnostic yield was attemptedby using a capsule with two cameras (one oneach side), which resulted in diagnosis of morelesions [10].

The main indications for SBCE include thefollowing:1. Obscure gastrointestinal bleeding2. Crohn’s disease (suspected/known)3. Suspected small bowel tumor4. Evaluation of abnormal small bowel imaging5. Partially/non-responsive celiac disease6. Surveillance of inherited polyposis syndromes7. Evaluation of drug-induced small bowel

injury and response to medications

Contraindications include the following:1. History of or suspected small bowel

obstruction2. Swallowing disorders3. Pregnancy4. Non-compliance

Relative contraindications are as follows:1. Major abdominal surgery in the previous

6 months.2. Cardiac devices—pacemaker/defibrillator.

Although the capsule is easily ingested andswallowed by most individuals, patients withsevere dysphagia, large Zenker’s diverticulum,pill phobia, significant gastroparesis, and smallchildren may have problems ingesting thedevice. For these situations, a capsule-loadingdevice (AdvanCE, US Endoscopy, Mentor,Ohio, USA) is available to directly deliver thecapsule into the stomach or duodenum.

In case of suspected small bowel obstruction,the use of a patency capsule (the AGILE cap-sule, Given Imaging, Yokneam, Israel) has beenshown to provide evidence of the functionalpatency of the gastrointestinal tract [10](Fig. 2.3). This system consists of a self-disin-tegrating capsule without a camera that containsradio frequency identification (RFID) tag and aRFID scanner. In a case of obstructive smallbowel pathology, the AGILE capsule disinte-grates within 30 h, and the remnants can passthrough even small orifices [11]. The radio-opaque capsule can be detected by plainabdominal X-ray.

2.1.3 Occult GI Bleeding

Occult GI bleeding accounts for up to two-thirdsof SBCE studies performed [12]. It was shownthat 20–38 % of patients with normal upper andlower endoscopy have significant intestinallesions [13, 14] (Fig. 2.5). SBCE has beenshown to be superior to push enteroscopy,abdominal computed tomography, abdominalmagnetic resonance and angiographic studies[15–18], and as good as balloon-assisted smallbowel enteroscopy [19], with diagnostic yieldbetween 39 and 90 % [20]. Moreover, the rate ofrebleeding in patients with occult GI bleedingand negative SBCE was found to be significantlylower (4.6 %) compared with those with apositive SBCE (48 %) [21].

This information will be covered in detailin the chapter on PillCam small bowel.

2.1.4 Crohn’s Disease

SBCE is an important tool both in the diagnosisand in the follow-up of Crohn’s disease. It isused to establish the diagnosis, to assess diseaseextent, severity, and disease activity, and toassess mucosal healing post-therapy (Fig. 2.6).

SBCE has a high diagnostic yield in suspectedCrohn’s disease. Moreover, for both known andsuspected Crohn’s disease, SBCE was found to


have a better incremental yield (ranging between15 and 44 %) compared with other modalities,including small bowel follow-through, computedtomography, MRI, ileo-colonoscopy, and pushenteroscopy [21]. Increase in the diagnostic yieldof SBCE can be achieved by selecting patientswith high pretest probability such as those withperianal disease and negative work-up, using theinternational conference on capsule endoscopy(ICCE) selection criteria and/or patients with highfecal calprotectin level.

SBCE may alter disease management ofpatients with known Crohn’s, by assessingmucosal healing after medical therapy. SBCE isthe only method, except for double-balloon ent-eroscopy, to accurately assess small bowelmucosal healing. SBCE was also found to beclinically useful for categorizing patients withindeterminate colitis, although negative SBCEstudy did not exclude further diagnosis ofCrohn’s.

The rate of SBCE retention in patients withsuspected Crohn’s disease is similar to the gen-eral population (1.4 %), but retention rates ofmore than 8 % were reported in patients withestablished Crohn’s disease.

2.1.5 Small Bowel Tumors

The introduction of SBCE had resulted in dou-bling the rate of diagnosis of small bowel tumorsto 6–9 % of patients undergoing SBCE for vari-ous indications, obscure GI bleeding being themost common indication. More than half of thetumors diagnosed were malignant. Adenocarci-noma is the most common malignant tumor, fol-lowed by carcinoids, lymphomas, sarcomas, andhamartomas [22]. Gastrointestinal stromal tumorsare the most frequent benign neoplasm (32 % ofall cases). Melanoma is the most common tumormetastasizing to the small bowel, althoughmetastases derived from colorectal cancer andhepatocellular carcinoma have also been repor-ted. Tumors are located most frequently in thejejunum (40–60 %), followed by the ileum(25–40 %), and the duodenum (15–20 %). Smallbowel tumors can be easily missed due to thepredominant submucosal and extraluminal

Panel A: Active bleeding

Panel B: Angioectasia

Panel C: Small bowel ulceration

Fig. 2.5 Causes for small bowel obscure bleeding

10 Z. Li et al.

location of the tumors. Specific indexes and scaleswere developed for improving the detection rateof small bowel tumors, including the SmoothProtruding Index on Capsule Endoscopy (SPICEscore) and an automated scale using multiscalewavelet-based analysis [23, 24].

More details will be provided in thechapter on PillCam SB.

2.1.6 Celiac Disease

SBCE has a role in both the diagnosis of celiacdisease and in the evaluation of gluten refractoryceliac disease (Fig. 2.7). SBCE provides high-resolution magnified view of the mucosa, easilyidentifying the endoscopic changes found inceliac such as scalloping, mosaic pattern, flatmucosa, loss of folds, and nodularity. In a recentpublished meta-analysis, SBCE had an overallpooled sensitivity of 89 % and specificity of

95 % for identifying celiac disease [25]. Ingluten non-responsive celiac disease, SBCE canbe used for investigating the small bowel fortumors (enteropathy-associated T-cell lym-phoma and adenocarcinoma) and ulcerative je-juno-ileitis (Fig. 2.7).

2.1.7 Inherited Polyposis Syndromes

SBCE was shown to be effective tool in detect-ing small bowel polyps in Peutz–Jegher syn-drome. It is especially effective in demonstratingsmall- and medium-size polyps. However, largepolyps are sometimes only demonstrated par-tially, and polyp location is not accurate [26].The duodenum is a potential pitfall as the cap-sule passes it very fast and thus may give false-negative results. The new SB3 SBCE mayimprove that with its six frames per secondmode. Coupling of SBCE with double-balloon

Capsule Endoscopy Findingsof Crohn’sDisease

Fig. 2.6 Small bowel Crohn’s disease


enteroscopy and polypectomy may offer an idealmethod of follow-up and treatment of thesepatients, possibly avoiding surgery.

Another indication for SBCE in this setting isfamilial adenomatosis polyposis (FAP) in whichone may find patients with duodenal polyps, aswell as small bowel polyps. However, the majorpapilla is not demonstrated effectively, andcomplementary examination with a side-viewduodenoscope is mandatory.

2.1.8 Monitoring Effects and SideEffects of Drugs

SBCE can be used to monitor deleterious effectsof drugs such as NSAIDs on small bowelmucosa. Lesions that can be found in thesepatients include erythema, erosions, smallulcerations, and weblike strictures. SBCE can beused to monitor the effect of drugs used to pro-tect against NSAIDs-induced small bowelinjury, to monitor the small bowel mucosalappearance in transplanted patients, to managegraft versus host disease, and, possibly, tomonitor mucosal healing of small bowel Crohn’sdisease after various medical treatments.

2.1.9 Capsule Retention

Capsule retention is the major complication ofSBCE. Very rarely this may end in bowelobstruction/perforation. High risk of retentionoccurs in patients on NSAIDs, with knownCrohn’s, with radiation enteritis, or with smallbowel tumors. Normal prior radiological exam-ination does not always protect from havingcapsule retention. Once retention is diagnosed(capsule not excreted 2 weeks after ingestion),endoscopic (balloon-assisted enteroscopy) orsurgical removal was shown to be effective. Theintervention not only allows removal of thecapsule, but also allows the offendingabnormality.

2.1.10 Esophageal Video CapsuleEndoscopy

In 2004, Given Imaging developed an esophagealvideo capsule (PillCam ESO) as a noninvasivedevice for the examination of the esophagus. Thesecond-generation esophageal capsule, the Pill-Cam ESO2 (Given Imaging, Yokneam, Israel),was FDA-approved for marketing in 2007

Fig. 2.7 Typical PillCamSB findings in celiacdisease

12 Z. Li et al.

(Fig. 2.8). The esophageal capsule endoscope(ECE) is a 26 9 11 mm capsule that differs fromthe SBCE in a few parameters: It has opticaldomes on both sides, the frame rate is much faster(9 frames from each side versus 2), a wider angleof view (169 vs. 156�), more advanced optics (3lenses), and a shorter battery life of up to 30 min,all aimed to address the very short time (\2 s) ofesophageal transit as well as the necessity todemonstrate the esophageal–gastric junction,where most of the esophageal pathology is loca-ted. It works for approximately 30 min and thenshuts off and passed through the intestine viaperistalsis and is naturally excreted.As in PillCamSB 3 system, or PillCam Colon2, real-timeviewing is feasible.

Procedure: Prolongation of the transit time ofthe capsule has been achieved by an alteration ofthe capsule ingestion technique, using the sim-plified ingestion procedure (SIP) (Fig. 2.9),wherethe patient swallows the capsule after at least 3 hof fasting, lying in the right lateral position whilesipping 15 mLofwater every 30 s through a straw[27]. The procedure requires up to 5 min in anunsedated patient. Thus far, no other esophagealcapsules are in the market. Competition includesattempts to attach a string to a Given Imagingsmall bowel capsule, the Given Imagingmagneticcapsule, and the Olympus gastric capsule whichare maneuvered with a joystick (Fig. 2.10).

Indications for ECE:• Screening for Barrett’s esophagus• Surveillance of esophageal varices in patientswith portal hypertension.

ECE is safe, well tolerated, and reported to bepreferred by patients to unsedated EGD. ECEwas found to have variable sensitivity andspecificity for the detection of GERD-relatedcomplications. Few studies reported very highspecificity and sensitivity for the detection oferosive esophagitis and Barrett’s esophagus(Fig. 2.11) [28, 29], while others found muchlower rates of sensitivity and specificity. Arecent meta-analysis of seven studies involving446 patients, ECE was found to have a sensi-tivity of 86 % and specificity 81 % in detectingesophageal varices (Fig. 2.12) [30].

Further details will be given in the chapteron Esophageal Capsule Endoscopy.

ECE may be used as an alternative to con-ventional upper GI endoscopy for the diagnosisof varices in complex patients with portalhypertension. It is most useful in certain patientgroups: patients who poorly tolerate endoscopyor who have significant comorbidity, thusincreasing the risks of repeated endoscopy, andpatients with high risk of variant Creutzfeldt–Jakob disease.

Although the major innovations and techno-logical advancement, at this point of time, ECEis not recommended as initial screening tool forthe mentioned conditions, mainly due to thelower cost and higher availability of upperendoscopy.

2.1.11 Colon Capsule Endoscopy

Colon capsule endoscopy (CCE) (Given Imag-ing Ltd., Yokneam, Israel) was introduced in2006 for the diagnosis of colonic pathologies,mainly polyps and tumors. In 2009, it wentthrough major upgrading when the second gen-eration of the capsule was introduced(Fig. 2.13). The second-generation capsule isslightly larger than the SBCE (31 9 11 mm) andhas two camera domes with an adaptive framerate of 4–35 frames per second, a 172� viewangle for each camera, and longer life of up to11 h due to the addition of a third battery andadvanced engineering techniques. As men-tioned, the frame rate can reach up to 35 frames

Fig. 2.8 PillCam ESOcapsule endoscope


per second depending on the capsule movementspeed in the colon and is determined using therevolutionized adaptive frame rate technique viaa cross talk between the capsule and the datarecorder (DR3). This new recorder is endowedwith artificial intelligence that communicates

with the capsule, as well as with the patient bybeeping and vibrating when the capsule leavesthe stomach and displaying on the LCD screen amessage that informs the patient to ingest abooster laxative which will accelerate the pas-sage of the capsule through the small bowel.

Procedure: As in colonoscopy, bowel prep-aration is compulsory in order to achieve ade-quate mucosal visualization. This is done using astrict preparation that includes liquid diet on theday prior to capsule ingestion, two doses of 2 lof PEG solution (on the evening prior to inges-tion and on the morning of the capsule inges-tion), as well as propulsive agents to enhancecapsule movement in the small bowel andadvance it to and through the colon, while thebattery is still working.

The main indication for CCE is colonic polypdetection (Table 2.1, Fig. 2.14). Colonicscreening programs in moderate- and high-riskgroups reduced the incidence, morbidity, andmortality due to colorectal carcinoma. However,

ECE Ingestion Procedure:

Original

002

min

300

2 m

in60

01

min

Simplified

ECE propelled by water (15cc every 30 sec)

Patient ingests ECE while lying

on right side

Fig. 2.9 Ingestion procedure for PillCam ESO capsule endoscope

Fig. 2.10 String capsule device. Reprint with permis-sion from Ramirez et al. [32]

14 Z. Li et al.

compliance rates to colonoscopy screening pro-grams are hampered due to fear of the inva-siveness and possible complications. CCEallows visualization of colonic mucosa with aminimally invasive procedure using no sedation,insufflation, or radiation and a practically com-plication-free method for colorectal screening.

Because noninvasive colorectal imaging testscannot provide a histological diagnosis, mor-phological criteria (i.e., polyp/mass C6 mm insize, or C3 polyps) are accepted as surrogatemarkers of advanced neoplasia. The averagesensitivity of the first generation of CCE forsignificant findings (C6 mm size, or C3 polyps

Fig. 2.11 PillCam ESO pictures of Barrett’s (a) and esophagitis (b)

(a)

(d) (e) (f)

(b) (c)

Fig. 2.12 a–f Images of Esophageal varices taken with Pillcom ESO


irrespective of size) was relatively low, but itsignificantly improved with the use of the sec-ond-generation CCE (49).

Indications: The latest guidelines publishedin 2012 by the European Society of Gastroin-testinal Endoscopy (ESGE) [31] state that:• CCE is feasible and safe and appears to beaccurate when used in average-riskindividuals.

• In patients with high risk for colorectal car-cinoma in whom colonoscopy is not possibleor not feasible, CCE could be a possible study.

• CCE is also a feasible and safe tool for visu-alization of the colonic mucosa in patientswith incomplete colonoscopy and withoutstenosis.Another possible indication for CCE is in the

diagnostic work-up or in the surveillance ofpatients with suspected or known inflammatorybowel disease (IBD), especially ulcerative coli-tis. Further details can be found in the chapter onColonic Capsule Endoscopy.

2.1.12 Summary

Since its introduction almost 13 years ago, theclinical indications for the use of capsuleendoscopy have widened considerably. Capsuleendoscopy has been proven to be a useful min-imally invasive tool in the exploration of theentire gastrointestinal tract, allowing visualiza-tion of previously inaccessible parts andachieving worthy satisfaction from both physi-cians and patients. New indications and future

possibility to control the capsule movementenabling new possibilities for diagnosis andtargeted therapy will evolve with the futuretechnologic advancement.

2.2 EndoCapsule

The EndoCapsule (Olympus, Tokyo, Japan) is avideo capsule endoscopy for the small intestineusing a charge-coupled device sensor instead ofa CMOS to acquire images (Fig. 2.15). Laun-ched in Europe in 2005, EndoCapsule obtainedFDA clearance in 2007 [33]. The EndoCapsuleconsists of a camera, light source, transmitter,and batteries. Once the capsule is activated andswallowed by the patient, it begins transmittingimages of the digestive system to a receiverworn by the patient. After the examination, thepatient returns the receiver to the physician or anurse who can download all images to a com-puter and find the abnormalities in small intes-tine (Fig. 2.16).

2.2.1 Special Characteristics [34]

1. High-resolution CCD2. Smart Recorder: It combines a receiver and

viewer in a compact and easy-to-handle unit,allowing the physician to playback and cap-ture images any time during the procedure.

3. 3D Track Function: That function offersintuitive operation, showing capsule locationto help you decide what approach should betaken for subsequent procedures.

2.2.2 Preparation

The bowel preparation of Endocapsule exami-nation includes a 12-h fast prior to the proce-dure, the administration of 2 l of polyethyleneglycol (PEG) solution in the evening and 1 l30 min before the procedure.

Fig. 2.13 PillCam Colon2 capsule endoscope

16 Z. Li et al.

2.2.3 Clinical Studies

In a British retrospective cohort study, 70patients performed Endocapsule examinationusing either overview with express-selected (ES)or overview with auto-speed-adjusted (ASA)modes. The ES-mode software eliminates

images with no significant changes (comparedwith the previous frames) in the video. And theASA-mode software speeds up the fps of the CE

Spectrum of Findings:

Fig. 2.14 Pathologies found with PillCam Colon2 capsule endoscope

Fig. 2.15 The Endocapsule. Reprint with permissionfrom Ogata et al. [38]

Fig. 2.16 Small intestinal villi detected by the Endo-capsule. Reprint with permission from Cave et al. [36]


video when detecting repetitive images. Among40 (57 %) patients found with clinically signif-icant findings, 32 (80 %) were recognized withoverview function alone, while 39 (97.5 %)were recognized with overview function plus ESor ASA modes. The average reading time foroverview with ES mode (19 ± 5 min) was sig-nificantly less than for overview with ASA mode(34 ± 10 min) (p = 0.001). These new play-back systems can efficaciously reduce readingtimes of CE but need further evaluation in pro-spective multicenter studies [35].

Cave et al. carried out a multicenter random-ized comparison of the Endocapsule and thePillCam SB in the USA. Results showed thepositive percent agreement of 70.6 % and anegative percent disagreement of 82.4 % with anoverall agreement of 74.5 %. The overall agree-ment was 74.5 % (38/51) with a j of 0.48 andP = 0.008. The study demonstrated that Endo-capsule had a similar diagnostic yield and betterimage quality compared with PillCam SB [36].

In another randomized head-to-head com-parison study in Austria, 50 patients were ran-domly assigned to swallow either the MiroCamfirst, followed by the EndoCapsule 2 h later, orvice versa. The MiroCam and EndoCapsuledevices were not statistically different withregard to their rates of complete small bowelexaminations (96 vs. 90 %) or diagnostic yield(50 vs. 48 %). However, the findings wereconcordant in 68 % only (kappa = 0.50). Thecombined diagnostic yield was 58 % [37].

2.3 OMOM Capsule EndoscopyPlatform

2.3.1 Overview

The creation of capsule endoscopy provides anew method for the visualized diagnosis ofdigestive diseases. It fixes the deficiency of thevisualized diagnosis of small bowel diseases andbrings a development direction of noninvasive,convenient, safe, and comfort diagnosis.

OMOM capsule endoscopy system is devel-oped by Chongqing Science and Technology(Group) Co. Ltd. Comparing with other similarproducts, the unique feature of duplex multi-channel communication mode has largelyincreased the controllability and convenience inits clinical use. Through the verification ofclinical application, the product has equalvalidity and yield rate comparing with othersimilar products from overseas in the diagnosisof small bowel diseases, such as obscure GIbleeding, Crohn’s disease, small bowel tumor,and small bowel polyp [39–41].

Since the first generation of OMOM capsuleendoscopy successfully created in 2004, Chon-gqing Jinshan Science and Technology has beendedicated to provide comprehensive solutions inthe diagnosis of digestive diseases. Based on thefirst generation of capsule endoscopy, the com-pany has developed various new capsuleendoscopy products according to different clin-ical uses, such as controllable capsule endos-copy, storable capsule endoscopy, and CCE, inwhich it can provide safe, noninvasive, comfort,and convenient visualized diagnosis for thewhole digestive tract.

After nearly 10 years of development,Chongqing Jinshan Science and Technology inthe field of digestive medical area has launcheda series of high-end products according to dif-ferent clinical uses, in which they are able toprovide accurate diagnosis of digestive tractdisease with comprehensive and personalizedsolutions. The following article will describe indetail about the application range, product for-mation, functions, and features of the products.

2.3.2 Small Bowel Capsule Endoscopy

OMOM small bowel capsule endoscopy ismainly used for visualized diagnosis of smallbowel diseases. It is a new diagnosis methodwhich is noninvasive, painless, safe, and com-fort. After swallowing the capsule, it will passthrough esophagus, stomach, duodenum, jeju-num, ileum, and colon and finally expel fromhuman body naturally by digestive tract

18 Z. Li et al.

peristalsis. The capsule will continuously cap-ture images of the GI tract during its movementprocess and transmit real-time image datawirelessly to the external image recorder. Afterthe monitoring process, doctors can replay andanalyze the saved images through the imageworkstation and finally make diagnosis of thegastrointestinal illness.

Small bowel capsule endoscopy system ismainly comprised of three parts: capsule, imagerecorder, and image workstation (Fig. 2.17), andfunctions of each part are described below:

Capsule: Capturing real-time image of GItract and transmitting image wirelessly to theexternal image recorder; meanwhile, it is able toreceive control signal from the image recorder toadjust working parameter.

Image recorder: Receiving and saving digi-tal images from the capsule; also, it is able tosend control signal to adjust the workingparameter of the capsule.

Image workstation: Man–machine interac-tive operation platform can monitor the workingcondition of the capsule in real time andadjusting its working status. It is able to down-load and replay image data from the imagerecorder, assisting doctors to make diagnosis.

Indications:1. GI hemorrhage, with no positive finding in

upper and lower GI tract endoscopicexamination;

2. Small intestine imaging anomaly suggestedby other examinations;

3. Any typeof IBDs, excludingbowel obstruction;4. Unexplained abdominal pain and diarrhea;5. Small intestine tumor (benign, malignant,

carcinoid, etc.);6. Unexplained iron-deficient anemia.

Contradictions:1. Patients who are confirmed (or suspected) to

suffer from digestive tract malformation,gastrointestinal obstruction, gastrointestinalperforation, stenosis, or fistula;

2. Patients implanted with pacemaker or otherelectronic devices;

3. Patients suffering from severe dysphagia;4. Patients suffering from acute enteritis or

severe iron deficiency, for example, bacillarydysentery at active phase and ulcerativecolitis at acute phase, particularly for patientssuffering from fulminant diseases;

5. Patients allergic to polymer material;6. Use with caution for patients below 18 and

above 70 and for psychopath;7. Pregnant woman.

2.3.2.1 Features• Pioneer of duplex communication

It supports duplex data transmission betweenthe capsule and the image recorder. The real-time monitoring function, which can check thecaptured images in real time during the

Fig. 2.17 Small bowel capsule endoscopy system formation


examination, can able to make intuitive judg-ment about the location of the capsule within theGI tract. At the same time, it can control theparameters of the capsule, such as capture fre-quency, brightness, and exposure, in order toextend the monitoring time (Fig. 2.18). Thisfunction has been widely spread in clinical use,and it can increase the completion rate of smallbowel examination up to 100 % [42, 43].• Unique multichannel mode

OMOM capsule endoscopy system supportssimultaneous activation of multiple capsules atthe same place, without interference betweeneach of the capsules. Currently, OMOM capsulehas 10 channels, which means it can undertake10 patients simultaneously at the same locationin the hospital without interference betweeneach other. The image workstation can simulta-neously monitor images from four capsules inreal time (Fig. 2.19).• Unique wireless USB monitoring

The wireless USB monitor is a convenienttool. It enables wireless communication, real-time monitoring, and capsule working parameteradjustment between the image recorder and theimage workstation.

2.3.2.2 Clinical ApplicationSince 2005, OMOM capsule endoscopy hasbeen used in clinic for over 8 years, and it hascompleted over 1 million samples. Clinicalcontrast study shows that OMOM capsuleendoscope comparing with PillCam SB byIsraeli company Given Imaging has no signifi-cant differences in the diagnosis of small boweldiseases, such as obscure GI bleeding, vascularmalformation, small bowel tumor, small bowelpolyp, and Crohn’s disease [44]. In addition,during the clinical use of OMOM capsule, itsspecial feature of duplex communication func-tion that enables real-time adjustment of imagecapture frequency can achieve 100 % comple-tion rate of small bowel examination [42].

In 2,400 patients who had OMOM capsuleexamination [45], the diagnostic yield of smallbowel diseases was 47.7 %. In all findings ofsmall bowel, 28.1 % was vascular malformation,18.9 % small bowel tumor, 10.4 % polyp, 7.9 %Crohn’s disease, 15 % mucosa injury and ulcers,5.2 % bleeding, 11.3 % parasite, diverticulum,and so on. Comparing with traditional clinicalmethods such as GI radiography and CT,OMOM capsule endoscopy can provide more

Fig. 2.18 Real-time monitoring and capsule working parameter adjustment

20 Z. Li et al.

intuitive and clear images of small bowel, whichis able to significantly increase the completesmall bowel examination rate (CSER) and yieldrate, and also, it provides more safety and reli-ability [46, 47]. At the same time, OMOMcapsule endoscopy can incorporate other diag-nostic methods such as double-balloon endos-copy in clinical use. It can further improve theCSER and yield rate, and it can help to confirmthe lesion position and features prior to the smallbowel surgery which is efficient to lower the riskand difficulty of the surgery, thus improving thesurgery succession rate [48, 49].

2.3.3 Controllable Capsule Endoscopy

OMOM controllable capsule endoscopy isdeveloped based on the small bowel capsuleendoscopy. It can not only be used for visualdiagnosis of small bowel, but can also achievemovement and angle control within the stomach.After swallowing the controllable capsule intothe stomach, an external controller can control

the capsule movement, posture, and angle fromoutside the body, which makes stomach exami-nation controllable and comprehensive. After thestomach examination, the capsule will enterduodenum, jejunum, and ileum through GI tractperistalsis, and after the complete visualizedexamination of small bowel, it will pass throughcolon and be expelled from the body naturally.The capsule will continuously capture imageswithin the stomach and small bowel during theexamination, and the images will be transmittedand stored into the external image recorderwirelessly. After the examination, doctors cananalyze the images and make diagnosis throughthe image workstation. The controllable capsuleendoscope has solved the problems of ordinarycapsule when undertaking stomach examination,such as large blind spot, insufficient observation,and high misdiagnose rate. It provides a pain-less, noninvasive, safe, and comfort method forstomach examination. Clinical study shows thatthe controllable capsule can achieve compre-hensive examination of stomach fundus, stom-ach antrum, stomach corner, and stomach body

Fig. 2.19 Real-time monitoring of four capsules


with high detection rate and low misdiagnoserate [50, 51].

Controllable capsule endoscopy system iscomprised of four parts: capsule, image recorder,image workstation, and controller (Fig. 2.20).

2.3.4 Storable Capsule Endoscope

Storable capsule endoscope uses a large capacitystorage module instead of traditional datatransmission module. The captured images willbe stored within the internal capsule memorymodule.

The advantages of storable capsule endo-scopes are as follows: Patients do not need towear an image recorder after swallowing thecapsule, and they only need to be aware of thetime of expelling the capsule from the body andcollecting it. Then, a unique data reading andimage viewing tool is used to process the imagesin order to make an analysis.

The storable capsule endoscope is disposable.The large capacity storage module contains8 GB of memory which can store over 120,000images. The working duration of the capsulereaches 15 h.

Storable capsule endoscope system is com-prised of three parts: capsule, data reader, andimage workstation.

Storable capsule endoscope is mainly usedfor the diagnosis of small bowel diseases such asunknown abdominal pain, GI hemorrhage, smallbowel tumor, and Crohn’s disease.

2.3.5 Colon Capsule Endoscope

Colon capsule endoscope is a painless, nonin-vasive, safe, and comfortable diagnose methodspecially designed for colon disease. Accordingto the physiological structure of colon and basedon traditional capsule endoscope, it augmentedmore features such as capsule controlling, posi-tion measurement, posture measurement, andadjustment. It can achieve to control the move-ment, posture, and position of the capsule withinthe whole colon. Colon capsule can be entered tothe colon through swallowing or anus insertion.The movement of the capsule can be fully con-trolled by the external controlling device. Thecapture images will be transmitted to the controlpanel in real time wirelessly, and adjust thecapsule posture and angle to ensure the com-prehensiveness and reliability of the examina-tion. Therefore, comprehensive diagnosis of thewhole colon can be achieved.

Colon capsule endoscope system is com-prised of three parts: colon capsule, controllingdevice, and control panel (Fig. 2.21).

Colon capsule endoscope system is mainlyused for the diagnosis of various colon diseasessuch as colon inflammation, ulcer, diverticulum,polyp, and tumor.

2.3.6 pH Capsule Wireless MonitoringSystem

Gastroesophageal reflux disease (GERD) is acommon digestive disease which affects10–20 % of European and American population[52], and this ratio is relatively lower in Asia, butit has an increasing trend [53]. Clinical researchshows that continuous pH monitoring withinesophagus is themost effective way of diagnosingGERD [54]. OMOM pH capsule wireless moni-toring system is mainly used to monitor the pHvalue inside the esophagus and make diagnosis ofGERD through detecting the change in pH value.

Fig. 2.20 Controller

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The pH capsule is sent and fixed on the mucosa ofthe esophagus through the catheter, and it willmonitor the pH value within the esophagus withthe sensor through 96 h of continuous examina-tion. Themonitored data will be transmitted to theexternal data recorder wirelessly, and the doctorcan make diagnosis by analyzing the continu-ously monitored pH data parameter through theworkstation after the examination is completed.The capsule will naturally drop off from themucosa and finally expel from the body.

Clinical application research shows thatOMOMpHcapsulewirelessmonitoring system issafe and efficient for diagnosing GERD. Longcontinuous monitoring time can reflect the statusof the gastroesophagus reflux, which leads to highGERD positive detection rate, and it can effec-tively evaluate the frequency and severity of thereflux [55]. Comparing with traditional pH mon-itoring method such as catheter-based monitoringand endoscopy, it has similar diagnosis effect, butwith easier and more convenient clinical opera-tion [56, 57]; also, longmonitoring time of 96 h isnot only effective for GERD diagnosis in the earlystage, but also effective for assisting therapeuticdecision in the later stage, and it evaluates theeffectiveness of medical treatment.

pH capsule wireless monitoring system ismainly comprised of three parts: pH capsule(including the catheter), data recorder, and dataanalyzing software.

Indications:1. Patients have classic symptoms of acid reflux or

heartburnand are consideredasGERDpatients;2. Patients suffer from unexplained chronic

pharyngitis, hoarseness, trachitis, or asthmaand are considered as those having extra-esophageal symptoms of GERD;

3. Patients who are considered as GERD patientsand are positive in PPI therapeutic test;

Contradictions:1. Patients who are confirmed (or suspected) to

suffer from upper esophageal or nasopha-ryngeal obstruction;

2. Patients who are confirmed (or suspected) tosuffer from esophageal varices according togastroscopy, clinical radiology, or otherexaminations;

3. Patients who are confirmed to suffer fromesophageal mucosa erosion according togastroscopy or other examinations;

4. Patients who are confirmed (or suspected) tosuffer from congenital digestive tract mal-formation, gastrointestinal obstruction, andperforation, stricture, or fistula of digestivetract according to clinical radiology or otherexaminations;

5. Patients who had bleeding tendency or gas-trointestinal bleeding in the recent 6 monthsor have taken anticoagulant drugs for a longperiod of time;

Fig. 2.21 Colon capsuleendoscope systemformation


6. Patients who suffer from heart disease and arenot stable;

7. Patients implanted with pacemaker or othermedical devices;

8. Patients who had history of allergy to poly-mer material.

2.3.7 Impedance–pH MonitoringSystem

Impedance–pH monitoring system is used forthe diagnosis of GERD, which is an alternativemethod of pH capsule wireless monitoring sys-tem. The principle of this product is that itintegrated both pH sensor and impedance sensor.The sensors are sent to the esophagus throughnose by using a catheter, they will continuouslymonitor the patient’s pH data and impedancedata within the esophagus, and the data will betransmitted to the external data recorder. Doc-tors can analyze the changes of pH data andimpedance data through the workstation, inorder to make the final diagnosis. Throughclinical study, the added impedance monitoringcan not only increase the reliability of diagnos-ing GERD, but also detect alkaline reflux, whichis valuable for comprehensive GERD monitor-ing and evaluation in clinical use [58, 59].

Impedance–pH monitoring system consists ofthree parts: catheter, data recorder, and dataanalyzing workstation.

2.3.8 Conclusion

Capsule endoscope has provided a new methodof diagnosing GI diseases in clinical use. Themedical field calls it as the development trend ofGI endoscopy in twenty-first century, and itbrings the third revolution in GI endoscopydevelopment history. Its existence has made thedevelopment trend of GI disease diagnosistoward noninvasive, convenient, safe, andcomfort.

OMOM capsule endoscope has entered forclinical use since 2005, and in 8 years of clinicaluse and research, it has verified this product as

an effective method of visualized diagnosis forGI diseases. Comparing with similar productssuch as PillCam by Given Imaging, EndoCap-sule by Olympus, and MiroCam by Intromedic,OMOM capsule endoscope has same diagnosiseffect with lower price which is more acceptableand affordable for patients. Based on OMOMcapsule endoscope, Chongqing Jinshan Scienceand Technology has developed a series of newproducts according to the clinical use of visu-alized diagnosis in GI diseases, such as con-trollable capsule endoscope and colon capsuleendoscope. At the same time, it has developedproducts for diagnosing GI function disorders,such as pH capsule wireless monitoring systemand impedance–pH monitoring system which isable to provide comprehensive solutions for GIdisease diagnosis.

With the development of new technologiesand applications in the field of medical appli-cation, the future research and application of theGI diagnostic technology will mainly carry outin three directions: (1) the application of mult-isensing and detection technology for morecomprehensive diagnostic information; (2) thedevelopment direction from minimal invasive tononinvasive; and (3) the development directionfrom diagnosis to diagnosis–treatment com-bined. The capsule endoscope will eventuallydevelop from a diagnostic tool to a diagnosis–treatment-combined intelligent robot.

2.4 MiroCam

2.4.1 Background of Development

Since the first development of a wireless capsuleendoscope, M2A, the prototype of PillCam(Given Imaging Yokneam, Israel) in 2000 [60],it has been widely applied in clinical practice forthe investigation of small bowel disease. Cap-sule endoscopy is easily performed only byswallowing the pill-sized capsule and so over-comes the limitations of conventional endoscopy

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handbook of capsule endoscopy

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