NCT01742494

Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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)

Conditions

• Esophageal Achalasia

Interventions

Type	Name	Description
PROCEDURE	Water-jet POEM	Water-jet assisted POEM procedure was performed
PROCEDURE	Conventional POEM	POEM were performed by the use of conventional technique using injection and triangle tip knife.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2012-12-05
• Last updated: 2012-12-05

Locations

1 site across 1 country: China