NCT02025790

POEM Versus Pneumatic Dilatation in Achalasia Cardia

A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achalasia Cardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-12-01
• First posted: 2014-01-01
• Last updated: 2014-01-01

Locations

1 site across 1 country: India