Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Phase 2
- Conditions
- Achalasia
- Interventions
- Procedure: Per Oral Endoscopic Myotomy
- Registration Number
- NCT01524471
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.
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Exclusion Criteria
-
Patients will be excluded from this study with the followings -
- Pregnancy
- Informed consent not available
- Previous history of esophagectomy or mediastinal surgery
- Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
- End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description POEM Per Oral Endoscopic Myotomy Endoscopic Myotomy
- Primary Outcome Measures
Name Time Method Dysphagia score
- Secondary Outcome Measures
Name Time Method Improvement in LES pressure Eckhart score Operative time Length of myotomy Time to resume diet Morbidities
Trial Locations
- Locations (1)
Department of Surgery, Chinese University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong