NCT01405417

Endoscopic Peroral Myotomy for Treatment of Achalasia

Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Peroral Myotomy	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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2017-09-01
• First posted: 2011-07-29
• Last updated: 2019-06-07

Locations

5 sites across 4 countries: Canada, Germany, Netherlands, Switzerland