- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025790
POEM Versus Pneumatic Dilatation in Achalasia Cardia
December 31, 2013 updated by: Nageshwar Reddy D, Asian Institute of Gastroenterology, India
A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: D Nageshwar Reddy, MD
- Phone Number: +914023378888
- Email: aigindia@yahoo.co.in
Study Locations
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, India, 500082
- Recruiting
- Asian institute of Gastroenterology
-
Contact:
- D Nageshwar Reddy, MD
- Phone Number: +914023378888
- Email: aigindia@yahoo.co.in
-
Contact:
- Mohan Ramchandani, MD
- Phone Number: +914023378888
- Email: ramchandanimohan@gmail.com
-
Sub-Investigator:
- Mohan Ramchandani, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
- Age 18-75 years
- 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:
- Severe comorbid illness
- Previous esophageal or gastric surgery
- Pseudo achalasia
- Achalasia with esophageal diverticula
- Pregnancy or lactation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A - POEM
Per Oral Endoscopic Myotomy for treatment of achalasia
|
|
ACTIVE_COMPARATOR: Group B - Dilatation
- Pneumatic dilatation using a balloon for treatment of achalasia.
|
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 1 week post procedure
|
All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution
|
1 week post procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pre procedure and immediately and 6 hours post procedure
|
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.
|
6 and 12 months post procedure
|
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.
|
3, 6 and12 months post procedure
|
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
|
3, 6 and 12 months post procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: D Nageshwar Reddy, MD, Asian Institute of Gastroenterology (AIG)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ANTICIPATED)
March 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
December 31, 2013
First Submitted That Met QC Criteria
December 31, 2013
First Posted (ESTIMATE)
January 1, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 31, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIG-POEM-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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