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The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - POEM | Experimental | Per Oral Endoscopic Myotomy for treatment of achalasia |
|
| Group B - Dilatation | Active Comparator | - Pneumatic dilatation using a balloon for treatment of achalasia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per Oral Endoscopic Myotomy (POEM) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution | 1 week post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine levels | 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 | Long term clinical success at 6 and 12 months post procedure compared to baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D Nageshwar Reddy, MD | Contact | +914023378888 | aigindia@yahoo.co.in |
| Name | Affiliation | Role |
|---|---|---|
| D Nageshwar Reddy, MD | Asian Institute of Gastroenterology (AIG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology | Recruiting | Hyderabad | Andhra Pradesh | 500082 | India |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Pneumatic Dilatation | Procedure | Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute. |
|
| 6 and 12 months post procedure |
| LES pressure | Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline. | 3, 6 and12 months post procedure |
| Quality of life | 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 |
| D004066 | Digestive System Diseases |