POEM Versus Pneumatic Dilatation in Achalasia Cardia

Study Overview
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Brief Summary
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The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.

Detailed Description
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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.

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

Conditions
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Achalasia Cardia

Intervention / Treatment
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* Procedure: Per Oral Endoscopic Myotomy (POEM)
* Procedure: Pneumatic Dilatation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - POEM<br>Per Oral Endoscopic Myotomy for treatment of achalasia | Procedure: Per Oral Endoscopic Myotomy (POEM)<br>* 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<br>|
| Active Comparator: Group B - Dilatation<br>- Pneumatic dilatation using a balloon for treatment of achalasia. | Procedure: Pneumatic Dilatation<br>* Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, POEM, Pneumatic dilatation, Eckardt score