POEM Versus Pneumatic Dilatation in Achalasia Cardia
|ClinicalTrials.gov Identifier: NCT02025790|
Recruitment Status : Unknown
Verified December 2013 by Nageshwar Reddy D, Asian Institute of Gastroenterology, India.
Recruitment status was: Recruiting
First Posted : January 1, 2014
Last Update Posted : January 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Achalasia Cardia||Procedure: Per Oral Endoscopic Myotomy (POEM) Procedure: Pneumatic Dilatation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Group A - POEM
Per Oral Endoscopic Myotomy for treatment of achalasia
Procedure: Per Oral Endoscopic Myotomy (POEM)
Active Comparator: Group B - Dilatation
- Pneumatic dilatation using a balloon for treatment of achalasia.
Procedure: Pneumatic Dilatation
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
- Clinical success [ Time Frame: 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
- Adverse events [ Time Frame: 1 week post procedure ]All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution
- Cytokine levels [ Time Frame: Pre procedure and immediately and 6 hours post procedure ]Post procedural inflammation compared to baseline as measured by blood cytokine levels
- Long term clinical success [ Time Frame: 6 and 12 months post procedure ]Long term clinical success at 6 and 12 months post procedure compared to baseline.
- LES pressure [ Time Frame: 3, 6 and12 months post procedure ]Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline.
- Quality of life [ Time Frame: 3, 6 and 12 months post procedure ]Quality of Life (QOL) improvement at 3, 6 and 12 months post procedure compared to baseline using SF36 questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025790
|Contact: D Nageshwar Reddy, MDemail@example.com|
|Asian Institute of Gastroenterology||Recruiting|
|Hyderabad, Andhra Pradesh, India, 500082|
|Contact: D Nageshwar Reddy, MD +914023378888 firstname.lastname@example.org|
|Contact: Mohan Ramchandani, MD +914023378888 email@example.com|
|Sub-Investigator: Mohan Ramchandani, MD|
|Principal Investigator:||D Nageshwar Reddy, MD||Asian Institute of Gastroenterology (AIG)|