Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A - POEM
Per Oral Endoscopic Myotomy for treatment of achalasia
Per Oral Endoscopic Myotomy (POEM)
* 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
Group B - Dilatation
\- Pneumatic dilatation using a balloon for treatment of achalasia.
Pneumatic Dilatation
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
Interventions
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Per Oral Endoscopic Myotomy (POEM)
* 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
Pneumatic Dilatation
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
Eligibility Criteria
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Inclusion Criteria
2. Age 18-75 years
3. 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
2. Previous esophageal or gastric surgery
3. Pseudo achalasia
4. Achalasia with esophageal diverticula
5. Pregnancy or lactation
18 Years
75 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Nageshwar Reddy D
Chairman
Principal Investigators
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D Nageshwar Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology (AIG)
Locations
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Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AIG-POEM-01
Identifier Type: -
Identifier Source: org_study_id
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