Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders

Not Applicable

Completed

• Conditions: Hypertensive LES; Achalasia
• Interventions: Procedure: Per Oral Endoscopic Myotomy

• Registration Number: NCT01525732
• 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

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Status Verified: 2017-04
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POEM	Per Oral Endoscopic Myotomy	Per Oral Endoscopic Myotomy

Primary Outcome Measures

Name	Time	Method
Dysphagia score before and after P.O.E.M.	From 1st day after POEM to within 2 weeks after POEM

Secondary Outcome Measures

Name	Time	Method
Eckardt score before and after P.O.E.M.	Before and 1 month after POEM
Post-operative pain	From Day 1 to until 2 weeks after POEM
Operative time	Up to 24 hours
Hospital stay	From day of admission till up to 30 days
Perioperative complication	30 days after operation

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong