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POEM Versus Pneumatic Dilatation in Achalasia Cardia

NCT02025790 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-01-01

No results posted yet for this study

Summary

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

Conditions

  • Achalasia Cardia

Interventions

PROCEDURE

Per Oral Endoscopic Myotomy (POEM)

* 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

PROCEDURE

Pneumatic Dilatation

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

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • D Nageshwar Reddy, MD · Asian Institute of Gastroenterology (AIG)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025790 on ClinicalTrials.gov