Role of Endoscopy in Gastroesophageal Reflux Disease

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1 Role of Endoscopy in Gastroesophageal Reflux Disease Joachim Mössner University of Leipzig Berlin, May 4, 2006

2 Role of Endoscopy in Gastroesophageal Reflux Disease In Diagnosis Magnifying endoscopy Chromoendoscopy NBI, narrow band imaging In Surveillance In Therapy

3 Barrett-Esophagus Methylene Blue Staining

4 Barrett-Esophagus Staining with Acetic Acid 99%

5 Confokal Laser Endomicroscopy Normal Endoscopy ~ 30X No microscopic details Zoom Endoscopy ~100X Crypts visible, but no details Confocal Endoscopy ~1000X Cellular resolution of crypts Kindly provided by R. Kiesslich/Mainz

6 Barrett-Esophagus Kara et al: High-resolution endoscopy plus chromoendoscopy or narrow-band imaging in Barrett's esophagus: a prospective randomized crossover study. Endoscopy 2005; 37: CONCLUSIONS: In most patients with highgrade dysplasia or early cancer in Barrett's esophagus, subtle lesions can be identified with high-resolution endoscopy. Indigo carmine chromoendoscopy and narrow-band imaging are comparable as adjuncts to high-resolution endoscopy.

7 Barrett-Esophagus Routine use of chromoendoscopy or NBI: No proof of greater early detection rate of neoplasia in addition to magnifying endoscopy

8 Gastroesophageal Reflux Disease Heart Burn 7% dayly 14% weekly 44% once per month Nebel et al, 1976 PPI: successful therapy in 85-92% relapse after stop of PPI s: 80% within 6 months Costs worldwide per year > 60 billion $

9 Reflux Disease - PPI - Gap Allergic side effects Heart burn at night High volume reflux Extra esophageal manifestations Anxiety to take drugs

10 Surgical Therapy Laparoscopic Fundoplication Problems of surgery: Indications: Precondition: Complications: effective medical treatment available persistant regurgitation, unwanted side effects, denial to take drugs continuously high volume, expert center, manometry vagus lesion, relapse, gas-bloat syndrom

11 GERD-Therapy without Drugs Laparoscopic Fundoplication Endoscopic Therapies Gastroplication (EndoCinch, ESD, Plicator) Radiofrequency application (Stretta, Curon Medical) Injektion of an inert polymer (Enteryx: no longer licensed, Gatekeeper)

12 Indications for Endoscopic Antireflux Therapy Impairment of quality of life due to drug therapy Alternative to continuous therapy with PPI Small axial hiatus hernia Important Symptoms & proof of reflux: endoscopy & ph-metry Manometry: exclusion of achalasia

13 EndoCinch Endoscopic Sewing System BARD Co. Several published studies

14 Patient: before EndoCinch

15 Endoscopic Fundoplication

16 Patient: 6 Weeks after EndoCinch

17 Patient before EndoCinch Pat. 6 weeks after EndoCinch

18 EndoCinch II - Clipsystem

19 EndoCinch: : US - Multi-Center Center-Study Prospective, multi center 64 patients with symptomatic reflux disease Post surveillance 1, 3, 6 months Inclusion - Exclusion Criteria GERD symptomatic Reflux esophagitis III/IV > 2/weeks BMI > 40 PPI/H2-Blocker con. therapy PPI refractory GERD positive response Hiatal hernia > 2 cm ph <4 more than 4% of time Filipi et al: Gastrointest Endosc 2001

20 EndoCinch: : US - Multi-Center Center-Study Heart burn symptom score (frequency x intensity) (N=64) HBSS p< Pre 1 mo 3 mo 6 mo Filipi et al: Gastrointest Endosc 2001

21 EndoCinch: : US - Multi-Center Center-Study Patients without Medication (< 4 Doses PPI/H 2 B /month) 80% 62 % 62 % (N=64) 60% % Patients 40% 20% 0 % 0% pre 3 mo 6 mo Filipi et al: Gastrointest Endosc 2001

22 DeMeester Symptom Score (Leipzig) 100% 80% 60% 40% 20% 0% 21% 56% before EndoCinch (n=48) 31% 38% 6 mo post-endocinch (n=32) 36% 27% 12 mo Post-EndoCinch (n=11)

23 24-hour ph-metry (Leipzig) % time ph < ,1 n=12 n=7 6 n=22 p<0,05 4,9 1 0 before EndoCinch 6 mo after EndoCinch

24 Endocinch: : Patients` Satisfaction Would you do it again? 16% 84% ja nein Would you recommend the procedure to friends? N = 43 21% yes 79% ja nein

25 EndoCinch - Effect on Symptoms n= Mean HSS RFS (f/u) F/U (mos) Filipi (2001) 64(47) 6 yes yes Park (2001) yes yes Patel (2001) yes yes Mahmood (2001) 20(11) 3 yes yes Maple (2001) 23(21) 6.7 yes yes Abdu-Rebyeh (2002) 16(14) < 3 yes ---- Liu (2002) 19(17) < 6 yes yes Caca (2002) 54(43) 6 yes yes Chen (2002) 183(42) 12 yes yes Arts (2002) 20 3 yes ----

26 Endocinch Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K: Long term failure of endoscopic gastroplication (EndoCinch). Gut 2005; 54: Comment in: Gut. 2005; 54: CONCLUSION: Endoscopic gastroplication (EndoCinch) is a safe and minimally invasive endoscopic treatment for GORD with reasonable short term results. In contrast, long term outcome is disappointing, probably due to suture loss in the majority of patients.

27 Endocinch: predictors of outcome? Schiefke I, Soeder H, Zabel-Langhennig A, Teich N, Neumann S, Borte G, Mossner J, Caca K: Endoluminal gastroplication: what are the predictors of outcome? Scand J Gastroenterol 2004; 39: Three variables were significantly predictive for successful endoscopic anti-reflux treatment at the multivariate level: presence of typical symptoms (P=0.01), complete symptom relief with acid suppressive therapy (P=0.01), and normal lower esophageal sphincter pressure (P = 0.04).

28 ESD: Flexible Endoscopic Sewing Device Wilson-Cook Medical No studies in GERD Animal studies regarding sewing technique First trials in humans FDA approval: soft tissue apposition In Europe not licensed

29 ESD: Flexible Endoscopic Sewing Device Wilson-Cook Medical

30 ESD Schiefke I, Neumann S, Zabel-Langhennig A, Moessner J, Caca K. Use of an endoscopic suturing device (the "ESD") to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure. Endoscopy 2005; 37: CONCLUSIONS: Endoluminal gastroplication using the ESD is an easy and safe, but unfortunately ineffective procedure for endoscopic GERD treatment. Endoluminal gastroplication techniques clearly need refinements before these therapies can evolve as a treatment option for GERD patients.

31 PLICATOR NDO Surgical

32 PLICATOR Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A: A novel endoscopic fullthickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc 2003; 58: CONCLUSIONS: Endoscopic full-thickness plication is feasible, safe and, in this pilot study, appeared to reduce symptoms and medication use associated with GERD.

33 Stretta Radiofrequency-Coagulation 12 published studies

34 Stretta Quality of Life: (GERD-HRQL) N=94 Triadafilopoulos et al: Gastrointest Endosc 2002

35 Stretta Sham-Control Control-Study 6 Months Sham (n=30) Stretta (n=34) Heartburn -0,6-1,6 p<0,01 GERD-HRQL p<0,05 SF p<0,05 Stop of PPI therapy -29% -46% n.s. 20 pats Cross-over: GERD-HRQL 2-11 Change in ph-metry or manometry but: ph-change in responder-subgroup Corley et al: Gastroenterology 2003

36 Injection of Biocompatible Polymers Enteryx TM Ethylene-Vinyl-Ethanol: Enteric Medical / Boston Scientific fatal complications no longer in use

37 Implantation of Polyacrylnitrol Gatekeeper - Medtronic

38 Stretta PPI EndoCinch X? Gatekeeper Plicator ESD Laparoscopic Fundoplication X

39 Peptic Esophageal Stenosis

40 Peptic Esophageal Stenosis after bouginage

41 Endoscopic Antireflux Therapy Summary Endoscopic anti reflux therapy at the beginning of a new aerea Techniques at present only partially successful No clear cut long term results No prospective randomized comparative data Limited indications detailled post surveillance mandatory

42 Summary Barrett-Esophagus Routine use of chromoendoscopy or NBI: No proof of greater early detection rate of neoplasia in addition to magnifying endoscopy

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