Clinical trial NCT01405417: Endoscopic Peroral Myotomy for Treatment of Achalasia
Official title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Achalasia
Keywords: Achalasia
Heller myotomy
Dysphagia
Peroral Endoscopic Myotomy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis
* persons of age \> 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
* Signed written informed consent.

Exclusion Criteria:

* Patients with previous surgery of the stomach or esophagus
* Patients with known coagulopathy
* Previous achalasia-treatment with surgery
* Patients with liver cirrhosis and/or esophageal varices
* Active esophagitis
* Eosinophilic esophagitis
* Barrett's esophagus
* Pregnancy
* Stricture of the esophagus
* Malignant or premalignant esophageal lesion
* Candida esophagitis
* Hiatal hernia \> 2cm

Primary outcomes:
measure: Eckhard symptom score at 3 month after peroral endoscopic myotomy
timeFrame: Score is evaluated at 3 month after peroral endoscopic myotomy
Secondary outcomes:
measure: Lower esophageal sphincter pressure
timeFrame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
measure: Reflux Symptoms
timeFrame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre
state: Quebec
city: Frankfurt am Main
country: Germany
facility: Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
city: Amsterdam
country: Netherlands
facility: Department of Gastroenterology and Hepatology, Academic Medical Center
city: Zürich
country: Switzerland
facility: Klinik für Gastroenterologie, USZ
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thomas Roesch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.