ingestible event marker system—a novel, physiologically-sized device platform for frequent,...

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333 Physician and Gender Differences Among the Patient-Physician Discussion Prior to Open Access Colonoscopy Dana Freeman, James Paulson, David A. Johnson, Michael J. Ryan, F Taylor Wootton, Jeff R. Willis, Kelvin Hornbuckle, Whitney D. Brooks, Stacy B. Menees Objective: In an effort to improve colorectal cancer screening (CRCS) compliance, open-access colonoscopy (OAC) is utilized to decrease the cost and waiting time for colonoscopy. The purpose of our study was to examine the patient-physician discussion prior to OAC to assess areas to improve CRCS compliance. Methods: A questionnaire was administered to consecutive patients undergoing OAC at a private gastroenterology practice. Patients reported demographics, provider information, discussion length, and content areas of the discussion. Results: 426 subjects completed the questionnaire of which 52% were women. 70.4% of participants were Caucasian and 22.1% were African American. The average age was 52.8 (þ5.3) yrs. Subjects had seen their primary care physicians (PCP) for 7.9(þ7.6) yrs and averaged two visits/yr. 63% of PCPs were male. 47.2% of referring physicians were family practice(FP), 39.2% were internists(IM), and 8.9% were gynecologists(GYN). Male subjects reported a mean 9.7 þ4.3 minutes of discussion about CRCS, colonoscopy procedure and preparation compared to women subjects at 7.6 þ4.3 min. The female physicians’ discussions were slightly longer than their male cohorts, 11.2 þ1.9 vs. 10.8 þ1.9 min, respectively. FPs(12.6 þ4.1 min) had the most extensive discussion regarding CRCS/OAC relative to IM(7.8 þ4.0 min) and GYN(6.7 þ4.8 min). 25% of subjects discussed other CRCS methods besides colonoscopy. Women were less likely than men to have discussed other forms of CRCS(OR 0.36, p!0.000). 57% of subjects discussed the benefits of CRCS. GYNs (OR 9.5, p!0.005) and IMs (OR 4.3, p!0.042) were most likely to discuss benefits of CRCS with subjects. 20% of subjects reported discussing the risks of OAC and 23% reported discussing the medications to avoid. Only 52% felt that they were adequately informed prior to OAC. Women were half as likely to be adequately informed by their practitioner (OR 0.40, p!0.000), the risks of colonoscopy (OR 0.45, p!0.005) and medications to avoid(OR 0.51, p!0.012). Of all PCPs, women felt that GYNs best informed them about their procedure (OR 12.5, p!0.005). Subjects with a relationship for 10 years or greater with their doctor were 43% more likely to be adequately informed(OR 1.43, p!0.00). Female physicians were the most influential in a patient’s decision to undergo a colonoscopy (OR 1.63, p!0.04). Conclusion: Despite the time devoted by PCPs, patients do not feel well informed about CRCS. Specifically, women are least likely to be informed about the CRCS process. In continuing to improve CRCS compliance, strategies must be in place to prompt PCPs to discuss the CRCS process with their patients. 334 Colorectal Cancer Screening Above Age 75: Outcomes of Colonoscopies in Symptomatic African American and Hispanic Adults Shashideep Singhal, Rinky Walia, Gokulakrishnan Balasubramanian, Arun Verma, Kris Anand Background: USPSTF recently updated colon cancer screening recommendations against routine screening for colorectal cancer in adults O 75 years of age. Considerations to support screening in an individual patient are not clearly described. There is limited data to support recommendations in African American and Hispanics population. This study evaluates the outcome of colonoscopies in symptomatic adults O 75 years of age. Methods: We reviewed records of 568 inpatient colonoscopies carried out at our center during 2006-2008 for symptomatic adults O 75 years of age. Subjects with one or more previous normal screening colonoscopies and presence of one or more ‘‘generally indicated’’ indications as per ASGE guidelines were included in study. Patients with history of diverticular bleed and inflammatory bowel disease were excluded. Results: A total of 155 adults (mean age 81.8 years; 29% males and 71% females; 83.8% African Americans and 16.1% Hispanics) met the inclusion criteria. Of the 155 patients studied, 79.35% had one previous colonoscopy whereas 20.6% of the patients had two or more previous colonoscopies. Indications for a repeat colonoscopy were: anemia 69.7%, hematochezia 39.4%, fecal occult blood 19.4%, chronic abdominal pain 12.9%, chronic diarrhea or constipation 12.2%, unexplained weight loss 9% and an abnormal CT scan 5.2%. Medications of significance consumed by these patients were: Asprin 48.4%, NSAIDS 13.5%, clopidrogel 4.5% and anticoagulants in 5.2%. Colonoscopy was completed to the caecum was in 65.2% of the subjects. In addition, 14.2% of the patients had poor bowel preparation. Clinically significant adenomas / cancer were found in 29/155 (18.7%) colonoscopies. Only 4.5% had tubular adenomas, 5.1% had villous adenomas, while cancer was detected in 14/155 (9%) colonoscopies. Of the fourteen patients with colon cancers, 9 (75%) were staged III or IV. Other findings were; diverticulosis 57.4%, hemorrhoids 16.8%, colitis 9.7% and angiodysplasias 1.3%. Only two patients from the study had significant complications - sinus bradycardia and bowel perforation which resolved with conservative management. Conclusion: Colonoscopy has a overall low yield in symptomatic African American and Hispanic patients greater than 75 years of age with previous normal screening colonoscopies. Although cancer detection rates were high, the advanced stages of cancer at diagnosis limited the benefit of detection in a significant proportion. 335 A Swallowable Tethered Capsule Endoscope for Diagnosing Barrett’s Esophagus Paul Glass, Metin Sitti, Arjun Pennathur, Ragunath Appasamy In this work, we present the concept for a swallowable, tethered esophageal capsule endoscope that combines the advantages of and avoids the drawbacks inherent in the techniques of traditional upper endoscopy and wireless capsule endoscopy which are currently used to diagnose patients suffering from Barrett’s esophagus. The proposed device is minimally invasive, eliminating the need for the conscious sedation required in traditional endoscopy. However, unlike a passive capsule endoscope, it is also controllable and capable of collecting biopsy specimens.The proposed device is 11 mm in diameter, 25 mm long, and consists of three subsystems: an anchoring subsystem which will allow the capsule to maintain a stable position despite being subjected to the body’s peristaltic contractions, an imaging subsystem similar to what is currently used in passive capsule endoscopy to allow the clinician to visualize the distal esophagus, and a biopsy subsystem capable of collecting and storing esophageal tissue specimens from targeted regions of the esophagus for later histological evaluation. The entire device is tethered by a thin multi-channel cable to keep all actuators and power sources off-board.The anchoring subsystem consists of an inflatable region of micro-patterned, biologically-inspired adhesives which, when inflated, is pressed into the esophagus lining. These adhesives are fabricated using a multistep lithographic and molding technique and are inspired by the structures found on the feet of animals such as geckos. Preliminary testing of these materials in contact with porcine esophagus has demonstrated as much as three times frictional enhancement over similar unpatterned materials. This controlled increase in friction between our prototype and the esophagus will allow the device to be securely anchored while the clinician performs any imaging or biopsy tasks.The biopsy subsystem consists of four individually controllable vacuum channels, evenly spaced around the perimeter of the prototype. Using a cable system and the on-board camera, the clinician can rotate a biopsy channel opening until it is aligned with a region of interest on the esophagus wall. A suction pressure is then applied to that channel, drawing some of the esophagus lining into the device. A sharp blade is used to collect and store the sample on board the device. Preliminary in vitro testing in excised porcine esophagus has demonstrated the viability of this concept. At the end of the procedure, the device is withdrawn from the patient by the tether. 336 Ingestible Event Marker SystemdA Novel, Physiologically-Sized Device Platform for Frequent, Repeated Use Michael Epstein Introduction: Ingestible diagnostics have been widely used to image the gut and measure internal physicochemical parameters. However, capsule size hampers accurate assessment of physiologic processes; system complexity and cost preclude use for longitudinal monitoring. An ideal ingestible tool would measure physiologic transit time with high detection accuracy at low cost. A novel ingestible event marker (IEM) system (Proteus, CA) comprises a physiologically sized 1mm sensor that is self-powered and a small, wearable receiver. EMITTER 1.0 is a first-in-human feasibility study to demonstrate the safety and performance of the IEM system. Methods: Twenty-five healthy subjects at a single site were enrolled in this 2-day study. Following overnight fasting, a receiver was placed using cables and skin electrodes around the xyphoid. This receiver detects unique identifying signals sent from each activated IEM and can differentiate multiple, simultaneously transmitting IEMs. Subjects then swallowed 68 active IEMs and 4 inactive IEMs, across 24 dosing intervals over 2 days. IEMs were delivered via an inert tablet carrier (2 IEM’s per tablet). A variety of meals (high protein, lipid, or carbohydrate) were given at scheduled times throughout each day. Technical performance was assessed using these metrics: 1) positive detection accuracy (PDA Z # active IEMs detected/# active IEMs administered), 2) identification accuracy (IA Z # IEMs correctly decoded/# IEMs detected), 3) negative detection accuracy (NDA Z # dummy IEMs not detected/# dummy IEMs administered. A follow-up visit occurred 1 week after final ingestion. Results: No device-related adverse events occurred after 1,670 IEM ingestions. PDA per IEM was 0.967 (CI Z 0.957-0.975), IA was 1.00 (CI Z 0.998-1.00), and NDA was 1.00 (CI Z 0.969-1.00, nZ96). Time-to-detection and IEM transmit time were 1.0 min (CI Z 0.9-1.1) and 7.3 min (CI Z 7.1-7.5), respectively. BMI (pZ0.336), activity (pZ0.362), and meal type (pZ0.151) were not significantly associated with PDA. (All CIs at 95%)DiscussionThe IEM system appears safe for repeated use and delivers a high level of detection accuracy across a range of patients. IEM transmission, detection, and identification occurred promptly and reliably when the devices entered the stomach; activation was not affected by BMI, activity or meal type. No false detections occurred. The IEM system offers promise as a new, physiologic platform that can be used to longitudinally track physical, chemical, and behavioral conditions and events. Additional studies are planned to investigate the system’s clinical utility in GI motility and transit disorders. Abstracts AB106 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009 www.giejournal.org

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Page 1: Ingestible Event Marker System—A Novel, Physiologically-Sized Device Platform for Frequent, Repeated Use

Abstracts

333

Physician and Gender Differences Among the Patient-Physician

Discussion Prior to Open Access ColonoscopyDana Freeman, James Paulson, David A. Johnson, Michael J. Ryan, FTaylor Wootton, Jeff R. Willis, Kelvin Hornbuckle, Whitney D. Brooks,Stacy B. MeneesObjective: In an effort to improve colorectal cancer screening (CRCS) compliance,open-access colonoscopy (OAC) is utilized to decrease the cost and waiting time forcolonoscopy. The purpose of our study was to examine the patient-physiciandiscussion prior to OAC to assess areas to improve CRCS compliance. Methods: Aquestionnaire was administered to consecutive patients undergoing OAC ata private gastroenterology practice. Patients reported demographics, providerinformation, discussion length, and content areas of the discussion. Results: 426subjects completed the questionnaire of which 52% were women. 70.4% ofparticipants were Caucasian and 22.1% were African American. The average age was52.8 (þ5.3) yrs. Subjects had seen their primary care physicians (PCP) for 7.9(þ7.6)yrs and averaged two visits/yr. 63% of PCPs were male. 47.2% of referring physicianswere family practice(FP), 39.2% were internists(IM), and 8.9% weregynecologists(GYN). Male subjects reported a mean 9.7 þ4.3 minutes of discussionabout CRCS, colonoscopy procedure and preparation compared to women subjectsat 7.6 þ4.3 min. The female physicians’ discussions were slightly longer than theirmale cohorts, 11.2 þ1.9 vs. 10.8 þ1.9 min, respectively. FPs(12.6 þ4.1 min) had themost extensive discussion regarding CRCS/OAC relative to IM(7.8 þ4.0 min) andGYN(6.7 þ4.8 min). 25% of subjects discussed other CRCS methods besidescolonoscopy. Women were less likely than men to have discussed other forms ofCRCS(OR 0.36, p!0.000). 57% of subjects discussed the benefits of CRCS. GYNs(OR 9.5, p!0.005) and IMs (OR 4.3, p!0.042) were most likely to discuss benefitsof CRCS with subjects. 20% of subjects reported discussing the risks of OAC and23% reported discussing the medications to avoid. Only 52% felt that they wereadequately informed prior to OAC. Women were half as likely to be adequatelyinformed by their practitioner (OR 0.40, p!0.000), the risks of colonoscopy (OR0.45, p!0.005) and medications to avoid(OR 0.51, p!0.012). Of all PCPs, womenfelt that GYNs best informed them about their procedure (OR 12.5, p!0.005).Subjects with a relationship for 10 years or greater with their doctor were 43% morelikely to be adequately informed(OR 1.43, p!0.00). Female physicians were themost influential in a patient’s decision to undergo a colonoscopy (OR 1.63,p!0.04). Conclusion: Despite the time devoted by PCPs, patients do not feel wellinformed about CRCS. Specifically, women are least likely to be informed about theCRCS process. In continuing to improve CRCS compliance, strategies must be inplace to prompt PCPs to discuss the CRCS process with their patients.

334

Colorectal Cancer Screening Above Age 75: Outcomes of

Colonoscopies in Symptomatic African American and Hispanic

AdultsShashideep Singhal, Rinky Walia, Gokulakrishnan Balasubramanian,Arun Verma, Kris AnandBackground: USPSTF recently updated colon cancer screening recommendationsagainst routine screening for colorectal cancer in adults O 75 years of age.Considerations to support screening in an individual patient are not clearlydescribed. There is limited data to support recommendations in African Americanand Hispanics population. This study evaluates the outcome of colonoscopies insymptomatic adults O 75 years of age. Methods: We reviewed records of 568inpatient colonoscopies carried out at our center during 2006-2008 forsymptomatic adults O 75 years of age. Subjects with one or more previous normalscreening colonoscopies and presence of one or more ‘‘generally indicated’’indications as per ASGE guidelines were included in study. Patients with history ofdiverticular bleed and inflammatory bowel disease were excluded. Results: A totalof 155 adults (mean age 81.8 years; 29% males and 71% females; 83.8% AfricanAmericans and 16.1% Hispanics) met the inclusion criteria. Of the 155 patientsstudied, 79.35% had one previous colonoscopy whereas 20.6% of the patients hadtwo or more previous colonoscopies. Indications for a repeat colonoscopy were:anemia 69.7%, hematochezia 39.4%, fecal occult blood 19.4%, chronic abdominalpain 12.9%, chronic diarrhea or constipation 12.2%, unexplained weight loss 9%and an abnormal CT scan 5.2%. Medications of significance consumed by thesepatients were: Asprin 48.4%, NSAIDS 13.5%, clopidrogel 4.5% and anticoagulants in5.2%. Colonoscopy was completed to the caecum was in 65.2% of the subjects. Inaddition, 14.2% of the patients had poor bowel preparation. Clinically significantadenomas / cancer were found in 29/155 (18.7%) colonoscopies. Only 4.5% hadtubular adenomas, 5.1% had villous adenomas, while cancer was detected in 14/155(9%) colonoscopies. Of the fourteen patients with colon cancers, 9 (75%) werestaged III or IV. Other findings were; diverticulosis 57.4%, hemorrhoids 16.8%,colitis 9.7% and angiodysplasias 1.3%. Only two patients from the study hadsignificant complications - sinus bradycardia and bowel perforation which resolvedwith conservative management. Conclusion: Colonoscopy has a overall low yield insymptomatic African American and Hispanic patients greater than 75 years of agewith previous normal screening colonoscopies. Although cancer detection rateswere high, the advanced stages of cancer at diagnosis limited the benefit ofdetection in a significant proportion.

AB106 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009

335

A Swallowable Tethered Capsule Endoscope for Diagnosing

Barrett’s EsophagusPaul Glass, Metin Sitti, Arjun Pennathur, Ragunath AppasamyIn this work, we present the concept for a swallowable, tethered esophagealcapsule endoscope that combines the advantages of and avoids the drawbacksinherent in the techniques of traditional upper endoscopy and wireless capsuleendoscopy which are currently used to diagnose patients suffering from Barrett’sesophagus. The proposed device is minimally invasive, eliminating the need forthe conscious sedation required in traditional endoscopy. However, unlikea passive capsule endoscope, it is also controllable and capable of collecting biopsyspecimens.The proposed device is 11 mm in diameter, 25 mm long, and consistsof three subsystems: an anchoring subsystem which will allow the capsule tomaintain a stable position despite being subjected to the body’s peristalticcontractions, an imaging subsystem similar to what is currently used in passivecapsule endoscopy to allow the clinician to visualize the distal esophagus, anda biopsy subsystem capable of collecting and storing esophageal tissue specimensfrom targeted regions of the esophagus for later histological evaluation. The entiredevice is tethered by a thin multi-channel cable to keep all actuators and powersources off-board.The anchoring subsystem consists of an inflatable region ofmicro-patterned, biologically-inspired adhesives which, when inflated, is pressedinto the esophagus lining. These adhesives are fabricated using a multisteplithographic and molding technique and are inspired by the structures found onthe feet of animals such as geckos. Preliminary testing of these materials in contactwith porcine esophagus has demonstrated as much as three times frictionalenhancement over similar unpatterned materials. This controlled increase infriction between our prototype and the esophagus will allow the device to besecurely anchored while the clinician performs any imaging or biopsy tasks.Thebiopsy subsystem consists of four individually controllable vacuum channels,evenly spaced around the perimeter of the prototype. Using a cable system andthe on-board camera, the clinician can rotate a biopsy channel opening until it isaligned with a region of interest on the esophagus wall. A suction pressure is thenapplied to that channel, drawing some of the esophagus lining into the device. Asharp blade is used to collect and store the sample on board the device.Preliminary in vitro testing in excised porcine esophagus has demonstrated theviability of this concept. At the end of the procedure, the device is withdrawn fromthe patient by the tether.

336

Ingestible Event Marker SystemdA Novel, Physiologically-Sized

Device Platform for Frequent, Repeated UseMichael EpsteinIntroduction: Ingestible diagnostics have been widely used to image the gut andmeasure internal physicochemical parameters. However, capsule size hampersaccurate assessment of physiologic processes; system complexity and costpreclude use for longitudinal monitoring. An ideal ingestible tool would measurephysiologic transit time with high detection accuracy at low cost. A novelingestible event marker (IEM) system (Proteus, CA) comprises a physiologicallysized 1mm sensor that is self-powered and a small, wearable receiver. EMITTER1.0 is a first-in-human feasibility study to demonstrate the safety andperformance of the IEM system. Methods: Twenty-five healthy subjects at a singlesite were enrolled in this 2-day study. Following overnight fasting, a receiver wasplaced using cables and skin electrodes around the xyphoid. This receiverdetects unique identifying signals sent from each activated IEM and candifferentiate multiple, simultaneously transmitting IEMs. Subjects then swallowed68 active IEMs and 4 inactive IEMs, across 24 dosing intervals over 2 days. IEMswere delivered via an inert tablet carrier (2 IEM’s per tablet). A variety of meals(high protein, lipid, or carbohydrate) were given at scheduled times throughouteach day. Technical performance was assessed using these metrics: 1) positivedetection accuracy (PDA Z # active IEMs detected/# active IEMs administered),2) identification accuracy (IA Z # IEMs correctly decoded/# IEMs detected), 3)negative detection accuracy (NDA Z # dummy IEMs not detected/# dummyIEMs administered. A follow-up visit occurred 1 week after final ingestion.Results: No device-related adverse events occurred after 1,670 IEM ingestions.PDA per IEM was 0.967 (CI Z 0.957-0.975), IA was 1.00 (CI Z 0.998-1.00), andNDA was 1.00 (CI Z 0.969-1.00, nZ96). Time-to-detection and IEM transmit timewere 1.0 min (CI Z 0.9-1.1) and 7.3 min (CI Z 7.1-7.5), respectively. BMI(pZ0.336), activity (pZ0.362), and meal type (pZ0.151) were not significantlyassociated with PDA. (All CIs at 95%)DiscussionThe IEM system appears safe forrepeated use and delivers a high level of detection accuracy across a range ofpatients. IEM transmission, detection, and identification occurred promptly andreliably when the devices entered the stomach; activation was not affected byBMI, activity or meal type. No false detections occurred. The IEM system offerspromise as a new, physiologic platform that can be used to longitudinally trackphysical, chemical, and behavioral conditions and events. Additional studies areplanned to investigate the system’s clinical utility in GI motility and transitdisorders.

www.giejournal.org