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

This study is currently recruiting participants.
Verified February 2012 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Philip Wai Yan Chiu, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01525732
First received: February 1, 2012
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Achalasia
Hypertensive LES
 Procedure: Per Oral Endoscopic Myotomy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Dysphagia score before and after P.O.E.M.

Secondary Outcome Measures:
  • Eckardt score before and after P.O.E.M.
  • Post-operative pain
  • Operative time
  • Hospital stay
  • Perioperative complication

Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
POEM
Per Oral Endoscopic Myotomy
 Procedure: Per Oral Endoscopic Myotomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525732

Contacts
Contact: Philip WY Chiu, MD 85226322627 philipchiu@surgery.cuhk.edu.hk

Locations
Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Philip WY Chiu, MD     85226322627     philipchiu@surgery.cuhk.edu.hk    
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philip Wai Yan Chiu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01525732     History of Changes
Other Study ID Numbers: CRE-2010_430
Study First Received: February 1, 2012
Last Updated: February 2, 2012
Health Authority: Hong Kong: The Chinese University of Hong Kong

Keywords provided by Chinese University of Hong Kong:
Achalasia, Hypertensive LES

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013