POEM Versus Pneumatic Dilatation in Achalasia Cardia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025790
|Contact: D Nageshwar Reddy, MDfirstname.lastname@example.org|
|Asian Institute of Gastroenterology||Recruiting|
|Hyderabad, Andhra Pradesh, India, 500082|
|Contact: D Nageshwar Reddy, MD +914023378888 email@example.com|
|Contact: Mohan Ramchandani, MD +914023378888 firstname.lastname@example.org|
|Sub-Investigator: Mohan Ramchandani, MD|
|Principal Investigator:||D Nageshwar Reddy, MD||Asian Institute of Gastroenterology (AIG)|