Back to resultsProspective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders (POEM)
Primary Purpose
Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Per-Oral Endoscopic Myotomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES
Eligibility Criteria
Inclusion Criteria:
- All patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.
Exclusion Criteria:
- Pregnancy
- Informed consent not available
- Previous history of esophagectomy or mediastinal surgery
- Previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
- End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow
Sites / Locations
- Prince of Wales Hospital, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
POEM
Arm Description
To perform myotomy using endoscopy through a long submucosal tunnel
Outcomes
Primary Outcome Measures
Relief of Dysphagia
Secondary Outcome Measures
Complication
Full Information
NCT ID
NCT01524458
First Posted
February 1, 2012
Last Updated
February 1, 2012
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01524458
Brief Title
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Acronym
POEM
Official Title
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES). Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary esophageal motility disorder in which the LES failed to relax with increased pressure. Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POEM
Arm Type
Experimental
Arm Description
To perform myotomy using endoscopy through a long submucosal tunnel
Intervention Type
Procedure
Intervention Name(s)
Per-Oral Endoscopic Myotomy
Intervention Description
To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel
Primary Outcome Measure Information:
Title
Relief of Dysphagia
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Complication
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.
Exclusion Criteria:
Pregnancy
Informed consent not available
Previous history of esophagectomy or mediastinal surgery
Previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip WY Chiu, MD
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
Organizational Affiliation
Dept of Surgery, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, M
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
12. IPD Sharing Statement
Learn more about this trial
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
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