POEM Versus Pneumatic Dilatation in Achalasia Cardia

Asian Institute of Gastroenterology, India

Status: Unknown

Conditions: Achalasia Cardia

Treatments: Procedure: Pneumatic Dilatation; Procedure: Per Oral Endoscopic Myotomy (POEM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02025790

AIG-POEM-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group A - POEM

Experimental group

Description:

Per Oral Endoscopic Myotomy for treatment of achalasia

Treatment:

Procedure: Per Oral Endoscopic Myotomy (POEM)

Group B - Dilatation

Active Comparator group

Description:

- Pneumatic dilatation using a balloon for treatment of achalasia.

Treatment:

Procedure: Pneumatic Dilatation