POEM Versus Pneumatic Dilatation in Achalasia Cardia

Not Applicable

• Conditions: Achalasia Cardia
• Interventions: Procedure: Per Oral Endoscopic Myotomy (POEM); Procedure: Pneumatic Dilatation

• Registration Number: NCT02025790
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.

Detailed Description

Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01
• Primary Completion: 2015-03
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
2. Age 18-75 years
3. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study

Exclusion Criteria

1. Severe comorbid illness
2. Previous esophageal or gastric surgery
3. Pseudo achalasia
4. Achalasia with esophageal diverticula
5. Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - POEM	Per Oral Endoscopic Myotomy (POEM)	Per Oral Endoscopic Myotomy for treatment of achalasia
Group B - Dilatation	Pneumatic Dilatation	- Pneumatic dilatation using a balloon for treatment of achalasia.

Primary Outcome Measures

Name	Time	Method
Clinical success	3 months post procedure	Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 week post procedure	All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Andhra Pradesh, India