NCT01405469

Endoscopic Peroral Myotomy for Treatment of Achalasia

Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (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 single center setting in Europe.

Detailed description

This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe. 16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy. Primary outcome: -eckhardt 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, esophagal-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. An electric generator 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
OTHER	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. An electric generator 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: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2016-11-01
• First posted: 2011-07-29
• Last updated: 2019-10-15
• Results posted: 2014-12-02

Locations

1 site across 1 country: Germany