POEM Versus Pneumatic Dilatation in Achalasia Cardia

N/AUnknownNCT02025790

Asian Institute of Gastroenterology, India140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Achalasia Cardia

Interventions

Per Oral Endoscopic Myotomy (POEM)PROCEDURE

* Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ). * Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ. * Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm. * Long endoscopic myotomy is performed 10 cm proximal to GEJ extending * Closure of mucosal entry: the mucosal incision is closed using hemostatic clips

Pneumatic DilatationPROCEDURE

Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, India

RECRUITING

Outcomes

Primary Outcomes

Clinical success

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

Time frame: 3 months post procedure

Secondary Outcomes

Adverse events

All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution

Time frame: 1 week post procedure

Central Contacts

D Nageshwar Reddy, MD

CONTACT

+914023378888 aigindia@yahoo.co.in

Data from ClinicalTrials.gov

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