Clinical Trial: Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique

Brief Summary: Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Detailed Summary:

Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)


Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: Procedure time in both groups [ Time Frame: during POEM procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome: clinical efficacy and safety [ Time Frame: during hospital stay and up to 1 year ]

bleeding complications, pneumothorax or pleural effusion requiring intervention


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: November 20, 2012
Date Started: August 2011
Date Completion: December 2012
Last Updated: December 2, 2012
Last Verified: December 2012