endoscopic treatment of gerd - lsge€¦ · treatment options for gerd sandhu et al. gut liver...
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UPDATE IN ENDOSCOPIC MANAGEMENT OF GERD
Najib AL GHOSSAINI, MDAin Wazein Medical Village
Gastroenterologist
Director Of Endoscopy Unit
LSGE meeting – December 7, 2018
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DISCLOSURES-Abbvie: Advisory board-Phenicia: Speaking-Wilson Cook: Support of Scientific activities-Boston Scientific: Support of Scientific activities-FujiFilm: Grant
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OUTLINE
-GERD overview-Available solutions:
• Medical treatment + lifestyle modifications• Surgical• Endoscopic
-Description of different endoscopic techniques-Trials / Metaanalyses-Conclusion
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GERD – MONTREAL DEFINITION
Vakil et al., Am J Gastroenterol 2006
HeartburnRegurgitatio
nChest pain
EsophagitisStrictureBarrett
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GLOBAL DISTRIBUTION OF THE BURDEN OF GERD
El-Serag et al. Gut 2014
27.80%25.90%
7.80%
33.10%
11.60%
23%
North America
Europe East Asia Middle East Australia South America
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CLASSIFICATION OF PATIENTS WITH HEARTBURNS – ROME IV
The phenotypes of patients with heartburn based on the Rome IV criteria.
Zhang et al. UEG journal 2018
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SELECTING THE RIGHT PATIENT
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REFLUX TESTING – LYON CONSENSUS
Endoscopy pH or pH impedance HRM
Conclusive evidence for
pathologic reflux
Borderline for conclusive evidence
Adjunctive for supportive evidence
Evidence against pathologic reflux
LA grades C and D esophagitis
Long segment Barret’s mucosa
Peptic esophageal stricture
AET>6%
LA grades A and B esophagtis AET 4-6%Reflux episodes 40-80
Hypotensive EGJ
Hiatal hernia
Esophageal hypomotility
Reflux symptom association
Reflux episodes > 80
Low MNBI
Low PSPWI
Histopathology (score)
Electron microscopy (DIS)
Low mucosal impedance
AET<4%Refluxepisodes < 40
Gyawali et al. Gut 2018MNBI Mean Nocturnal Baseline Impedance
PSPWI Post-Reflux Swallow-Induced Peristaltic Wave Index HRM high resolujtion manometryAET acid exposure time
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ROME IV – OVERLAP GERD / FUNCTIONAL SYMPTOMS
Aziz et al. Gastroenterology 2016
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Aziz et al. Gastroenterology 2016
ROME IV – OVERLAP GERD / FUNCTIONAL SYMPTOMS
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TREATMENT OPTIONS FOR GERD
Sandhu et al. Gut Liver 2018; 12(1):7-16
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GERD MANAGEMENT ALGORITHM
Persisting symptoms
Suspected GERD
PPI therapy
Consider other causes
Endoscopy if risk factors or alarm symptoms
Consider surgery or endoscopic therapy
Endoscopy and24 h pH/impedence metry
on PPI
Double dose PPI
Maintenance therapy
Resolution No improvement
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REFRACTORY GERD
10 – 40% do not respond to PPI BID
Crawley et al. J Clin Outcomes Manag 2000; 7:29.Fass et al. J Gastroenterol Hepatol 2012; 27 Suppl 3:3El-Serag et al. Aliment Pharmacol Ther 2010; 32:720
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LONG TERM USE OF PPIFDA warnings:
• Clostridium difficile infection,
• Bone fractures,
• Hypomagnesemia,
• Higher incidence of chronic kidney disease in susceptible populations
• Vitamin B12 def
Strand et al. Gut Liver 2017 Jan; 11(1): 27–37
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Esophagealhypomotility
SURGICAL FUNDOPLICATION
-surgical fundoplication-Not recommended in patients who do not respond to PPI therapy
-Suggested for patients not responsive to PPIs but with documented reflux on pH-impedance analysis
-Preoperative ambulatory pH monitoring is mandatory in patients withoutevidence of erosive esophagitis. R/O achalasia or scleroderma.
-Surgery is as effective as medical therapy for carefully selected patients with chronic GERD when performed by an experienced surgeon.
Philip O. Katz et al. Am J Gastroenterol 2013; 108:308–328
270°
total
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LAPAROSCOPIC FUNDOPLICATIONDRAWBACKS
• 25% of patients restart PPI on long term follow up
• 15-30% of patients need reintervention
• Dysphagia
• Bloating
• Inability to belch
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ENDOSCOPIC ANTI-REFLUX TREATMENT
Nabi et al. Clin Endosc 2016
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TYPES OF ENDOSCOPIC TREATMENT
Transoral incisionless fundoplication (TIF) using: EsophyX device - 2007 Medigus Ultrasonic Surgical Endostapler (MUSE) - 2015 Endoscopic plication device (GERDx™) - 2018
Radiofrequency energy delivery to lower esophageal sphincter usingSTRETTA device - 2000/updated in 2007
Mucosal resection: Anti-reflux mucosectomy (ARMS) described in 2014
Previously developed endoscopic anti-reflux devices no longer marketedbecause of safety concerns and lack of efficacy: EndoCinch device (CR Bard, Inc, Murray Hill, NJ, USA) Endoscopic Suture device (Wilson-Cook, Winston-Salem, NC, USA) Endoscopic Plication System (Plicator; NDO Surgical, Inc, Mansfield
Mass, USA) Enteryx (Boston Scientific Corp, Boston, Mass, USA)
Rouphael et al. Curr Treat Options Gastroeterol 2018Nabi et al. Clin Endosc 2016
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Figure 1
Gastrointestinal Endoscopy 2017 86, 931-948DOI: (10.1016/j.gie.2017.08.001)
EsophyX2 HD device. (A) Tip and (B) control body
(EndoGastric Solutions, Redmond, Washington)
ENDOSCOPIC ANTI-REFLUX DEVICES - TIF
Thosani et al. GIE 2017;86(6),931-948
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Figure 3
TIF (transoral incisionless fundoplication) 2.0 procedure
(EsophyX device; EndoGastric Solutions, Redmond, Washington).
ENDOSCOPIC ANTI-REFLUX DEVICES -TIF
Thosani et al. GIE 2017;86(6),931-948
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PROCEDURE EVOLUTION
Gerson et al. Chirurgia 2018
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Figure 4
Gastrointestinal Endoscopy 2017 86, 931-948DOI: (10.1016/j.gie.2017.08.001)
ENDOSCOPIC ANTI-REFLUX DEVICES- MUSE
A, MUSE console and (B) tip of the endoscope
(Medigus Ltd, Omer, Israel)Thosani et al. GIE 2017;86(6),931-948
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Figure 5
Gastrointestinal Endoscopy 2017 86, 931-948DOI: (10.1016/j.gie.2017.08.001)
ENDOSCOPIC ANTI-REFLUX DEVICES - MUSE
MUSE procedure. A, retroflexion. B, stapling. C,recreated GE junction
(Medigus Ltd, Omer, Israel)
Thosani et al. GIE 2017;86(6),931-948
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Figure 6
Gastrointestinal Endoscopy 2017 86, 931-948DOI: (10.1016/j.gie.2017.08.001)
ENDOSCOPIC ANTI-REFLUX DEVICES
Stretta catheter (Mederi Therapeutics, Greenwich, Connecticut).
Thosani et al. GIE 2017;86(6),931-948
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Figure 7
Gastrointestinal Endoscopy 2017 86, 931-948DOI: (10.1016/j.gie.2017.08.001)
ENDOSCOPIC ANTI-REFLUX DEVICES
Thosani et al. GIE 2017;86(6),931-948
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GERDX
Weitzendorfer et al. Surgical endosc 2018
GERDx™ (G-SURG GmbH, Seeon-Seebruck, Germany)
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MUCOSECTOMY(ARMS)
• Semi-circumferential mucosectomy in the gastric cardia
• The artificial ulcer heals with shrinkage and contracture of mucosal defect
• Creation of an artificial flap valve at gastric cardia.
Inoue et al. Gastrointest endosc 2017
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COMPARATIVE COST
Thosani et al. GIE 2017
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GERD-HRQL SCORE
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TIF
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INDICATION OF TIF-Patient > 18 y o -GERD that REQUIRES AND RESPONDS TO pharmaceutical therapy-hiatal hernia < 2 cm-BMI < 35
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RISK OF TIF PROCEDURE-Sore throat, hoarseness, globus-Temporary dysphagia-Nausea, vomiting-Left shoulder pain from CO2 insufflation-Temporary abdominal pain
Mild adverse reactions in 25% of patientsSerious adverse events in 0.5% of patients
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CONTRA-INDICATIONS FOR TIF- Bleeding disorder- Stricture or severe esophagitis- Large hernia > 2 cm- Esophageal varices- Esophageal candidiasis- Less than 18 y o- BMI > 35
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RESPECT STUDYRandomized, blinded, sham- and placebo-controlled study
TIF/placebo n=87; SHAM/PPI n=42
Hunter et al. Gastroenterology 2015
1
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TEMPOTRIAL
Trad et al. Surgical innovation (2015)
Randomized trial 63 patients-40 TIF-23 PPIFollowed 6 months
2
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TEMPO TRIALThe 3 major findings :(a) TIF was more effective than PPIs in elimination of
troublesome regurgitation(b) 90% of TIF patients were completely off PPIs at 6-month (c) TIF was equivalent to PPIs in normalizing distal
Esophageal Acid Exposure
Trad et al. Surgical innovation (2015)
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TIF VS. SHAM TO CONTROL CHRONIC GERD Time in clinical remission
after either TIF or sham intervention during the 6 months of follow‐up.
3
44 patients:22 in each arm
Håkansson et al. Aliment Pharmacol Ther. 2015
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TIF VS. SHAM TO CONTROL CHRONIC GERD
Total acid exposure in % by pH recordings at baseline and after 6 months post‐therapy in the active intervention group (TIF) and in the sham group.
Håkansson et al. Aliment Pharmacol Ther. 2015
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METAANALYSIS OF THE 3 RCT’S
• At 3 years (Comparison to PPI or sham procedure):
- improved esophageal pH- decrease in PPI utilization,- improved quality of life.
Gerson et al. Chirurgia 2018
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METAANALYSIS OF THE 3 RCT’S
Gerson et al. Chirurgia 2018
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MUSE
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ENDOSCOPIC FUNDOPLICATIONWITH MUSE™: 6-MONTH RESULTS
- Multi-center prospective trial- 69 patients
At 6 months, 50 % reduction in GERD-HRQL score (off PPI) was achieved in 48 of 66 patients (73%),
-Primary endpoint > 50 % improvement in GERDHRQL score
Zacherl et al. Surg endosc 2015
1
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Long-term F/U of GERD treatment withMUSE™ endoscopic stapling device
Efficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post procedure.
Patients who remained off daily PPI were 83.8 % (31/37) at 6 monthsand 69.4 % (25/36) at 4 years post-procedure.
Kim et al. Surgical endosc 2016
2
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STRETTAAdvantages:-under conscious sedation as a day care procedure-duration is short, -safety and efficacy have been studied > 10 y. -Does not prevent subsequent therapy like surgery if required.
Drawbacks :-wide variability in response rates (16% to 86%) -low rate of improvement in objective parameters (acid exposure time)-Complete cessation of PPI in only 40% of patients -Patients with large hiatal hernia and severe esophagitis are not ideal candidates for RFA.
Adverse events:-chest pain (50%), -transient fever,-esophageal ulcers. -Gastroparesis
Nabi et al. Clin Endosc 2016
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IMPROVEMENT OF GERD AFTERRADIOFREQUENCY : A RANDOMIZED, SHAM-CONTROLLED TRIAL
Corley et al. Gastroenterology 2003
1
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STRETTA - CHANGE IN MEAN GERD HRQL
Significant difference between active and Sham treatment at 6 months (P 0.003)
Corley et al. Gastroenterology 2003
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STRETTA – DECREASE IN PPI USE AT 6 MONTHS
Corley et al. Gastroenterology 2003
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MULTICENTER RANDOMIZED, DOUBLE-BLINDED, CONTROLLEDTRIAL (WITHOUT SHAM PROCEDURE)
2
Coron et al. Alim Pharmacol Ther 2008
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STRETTA SINGLE/DOUBLE DOSE VS SHAM
3
Improvement at 12 months:-HRQL scores-LES basal pressure-24-hour pH scores-daily PPI use
In single and double Strettagroups (P < 0.01)
Aziz et al. Surg Endosc 2010
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METAANALYSIS OF THE AVAILABLE RCT’S – LIPKA ET AL.-165 patients from 4 RCTs-compared Stretta a sham or to PPI
No difference between the Stretta versus sham groups or Stretta versus PPI groups for:-(%) of time esophageal pH <4 / 24 h-LES pressure-ability to stop PPI therapy -GERD-HRQL
Lipka et al. Clinical Gastroenterol Hepatol 2015
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METAANALYSIS OF THE AVAILABLE RCT’S – LIPKA ET AL.
Lipka et al. Clinical Gastroenterol Hepatol 2015
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METAANALYSIS OF THE AVAILABLE RCT’S – LIPKA ET AL.
Lipka et al. Clinical Gastroenterol Hepatol 2015
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METAANALYSIS OF RCT’S AND COHORT STUDIES- HRQL
Fass et al. Surg Endosc 2017
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METAANALYSIS OF RCT’S AND COHORT STUDIES – HEARTBURN SYMPTOM SCORE
Fass et al. Surg Endosc 2017
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METAANALYSIS OF RCT’S AND COHORT STUDIES – RELIANCE ON PPI
Fass et al. Surg Endosc 2017
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RESULTS
• Significant improvement of: • HRQL• heartburn score • erosive esophagitis incidence.
• Significant reduction of:• PPI use • esophageal acid exposure
• No significant effect on LES basal pressure.
• Safety profile is excellent with only 1% AE rate.
Fass et al. Surg Endosc 2017
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GERDX™
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GERDX™• Only one study available• Single-arm study• 40 patients included, 30 studied• Results are encouraging but further studies are required• The technique improves the distal acid exposure of the
esophagus, typical reflux-related symptoms and QoL in well-selected patients.
Weitzendorfer et al. Surgical endosc 2018
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MUCOSECTOMY
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ARMS(SEMI-CIRCUMFERENTIAL MUCOSECTOMY)
• 67 consecutive cases• Symptoms of GERD improved significantly after ARMS• GERD Q score decreased from 9.9 to 5.7 (P<0.01) at 2
months after therapy. • Symptom improvement was kept one year after.• Improvement of pH impedance monitoring from 22.8% to
7.0% (P<0.05). • PPI was stopped in 61% at 1 y.
Inoue et al. GIE 2017
GERD Q score 0-12
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ARMS• Conclusion: • Results strongly suggest the short-term effectiveness of
ARMS for refractory GERD. • Long-term follow-up data will be awaited.
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COMPARISON OF TIF AND STRETTASYSTEMATIC REVIEW AND METAANALYSIS
• No RCT to compare these 2 techniques.
• Limitations of this article:• The total sample size of 397 is small
(Stretta n=101, TIF n=296)
• Author conclude that both Stretta and TIF can fill the therapy gap between PPI medication and laparoscopic fundoplication.
• Both methods are relatively safe, however, TIF could be superior to Stretta
Obuobi et al. Int Surg J. 2018
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COMPARISION OF DIFFERENT ENDOSCOPIC TECHNIQUES
Nabi et al. Clin Endosc 2016
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TAKE HOME MESSAGES-PPIs remain the cornerstone of medical management of GERD
-Endoscopic treatment is not meant to replace PPIs
-They may bridge the unmet gap between PPIs and surgery
-More studies with long-term follow-up and randomized comparisons are required to establish the role of endoscopic treatment in the management of GERD.
-Studies assessing the predictive factors for response or non-response will help in minimizing failures and maximizing efficacy.
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