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Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders (POEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01524458
First received: February 1, 2012
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Primary Esophageal Motility Disorders Including Achalasia and 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:
  • Relief of Dysphagia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: July 2010
Arms Assigned Interventions
Experimental: POEM
To perform myotomy using endoscopy through a long submucosal tunnel
 Procedure: Per-Oral Endoscopic Myotomy
To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524458

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

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Philip WY Chiu, M     85226322627     philipchiu@surgery.cuhk.edu.hk    
Principal Investigator: Philip WY Chiu, MD            
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Philip WY Chiu, MD Dept of Surgery, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Philip WY Chiu, Professor, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01524458     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: The Chinese University of Hong Kong

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

ClinicalTrials.gov processed this record on May 23, 2013