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This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s
70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.
Primary outcome:
-Eckhard symptom score 3 month after therapy.
Secondary outcomes:
Lower esophageal sphincter pressure at 3 month after therapy. Reflux symptoms at 3 month after therapy. For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peroral endoscopic myotomy | Experimental | Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy. Peroral endoscopic myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Peroral Myotomy | Procedure | Endoscopic peroral myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips. |
| Measure | Description | Time Frame |
|---|---|---|
| Eckhard symptom score at 3 month after peroral endoscopic myotomy | Validated symptom score based on dysphagia, pain, regurgitation and weight loss | Score is evaluated at 3 month after peroral endoscopic myotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Lower esophageal sphincter pressure | Manometry study | Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy |
| Reflux Symptoms | Symptoms as reported by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Roesch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20354937 | Background | Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. | |
| 22068665 | Background | von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8. |
| Label | URL |
|---|---|
| University Hospital Hamburg-Eppendorf, Endoscopy Department | View source |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy |
| Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus |
| Frankfurt am Main |
| 60431 |
| Germany |
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie | Hamburg | 20246 | Germany |
| Department of Gastroenterology and Hepatology, Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| Klinik für Gastroenterologie, USZ | Zurich | Switzerland |
| 23665071 | Result | Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9. |
| 25934759 | Result | Werner YB, Costamagna G, Swanstrom LL, von Renteln D, Familiari P, Sharata AM, Noder T, Schachschal G, Kersten JF, Rosch T. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016 Jun;65(6):899-906. doi: 10.1136/gutjnl-2014-308649. Epub 2015 Apr 30. |
| 27609778 | Result | Werner YB, von Renteln D, Noder T, Schachschal G, Denzer UW, Groth S, Nast JF, Kersten JF, Petzoldt M, Adam G, Mann O, Repici A, Hassan C, Rosch T. Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 10.1016/j.gie.2016.08.033. Epub 2016 Sep 5. |
| 29546671 | Derived | Nast JF, Berliner C, Rosch T, von Renteln D, Noder T, Schachschal G, Groth S, Ittrich H, Kersten JF, Adam G, Werner YB. Endoscopy versus radiology in post-procedural monitoring after peroral endoscopic myotomy (POEM). Surg Endosc. 2018 Sep;32(9):3956-3963. doi: 10.1007/s00464-018-6137-9. Epub 2018 Mar 15. |
| 27747277 | Derived | Verlaan T, Ponds FA, Bastiaansen BA, Bredenoord AJ, Fockens P. Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM). Endosc Int Open. 2016 Oct;4(10):E1052-E1056. doi: 10.1055/s-0042-113126. Epub 2016 Sep 21. |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |