Text Size

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

This study is currently recruiting participants.
Verified January 2012 by Chinese University of Hong Kong
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01524471
First received: February 1, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  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
 Procedure: Per Oral Endoscopic Myotomy
 Phase 2

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

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in LES pressure
  • Eckhart score
  • Operative time
  • Length of myotomy
  • Time to resume diet
  • Morbidities

Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POEM
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 Investigations before and after POEM
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524471

Contacts
Contact: Philip WY Chiu, MD 26322627 philipchiu@surgery.cuhk.edu.hk

Locations
Hong Kong
Department of Surgery, Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong, 00000
Contact: Philip WY Chiu, MD     26322627     philipchiu@surgery.cuhk.edu.hk    
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01524471     History of Changes
Other Study ID Numbers: CRE_2010.430
Study First Received: February 1, 2012
Last Updated: February 1, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Chinese University of Hong Kong:
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 May 19, 2013