Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Not Applicable

• Conditions: Esophageal Achalasia
• Interventions: Procedure: Water-jet POEM; Procedure: Conventional POEM

• Registration Number: NCT01742494
• Lead Sponsor: Shanghai Zhongshan Hospital

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 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)

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-04
• Study First Submitted: 2012-11-20
• Status Verified: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2012-12-02
• Last Update Submitted: 2012-12-02
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• With an Eckardt symptom score ≥ 4
• The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
• Informed patient consent was obtained

Exclusion Criteria

• Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
• Pseudoachalasia
• Megaesophagus (diameter of > 7 cm)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water-jet POEM	Water-jet POEM	POEM were performed by the use of Erbe Hybrid knife (WJ group)
Conventional POEM	Conventional POEM	POEM were performed by the conventional technique using injection and triangle tip knife (C group).

Primary Outcome Measures

Name	Time	Method
Procedure time in both groups	during POEM procedure

Secondary Outcome Measures

Name	Time	Method
clinical efficacy and safety	during hospital stay and up to 1 year	bleeding complications, pneumothorax or pleural effusion requiring intervention

Trial Locations

Locations (1)

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China