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

This study has been completed.
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: April 27, 2017
Last verified: April 2017
  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
Achalasia
Hypertensive LES
Procedure: Per Oral Endoscopic Myotomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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:


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

Primary Outcome Measures:
  • Dysphagia score before and after P.O.E.M. [ Time Frame: From 1st day after POEM to within 2 weeks after POEM ]

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

Enrollment: 50
Study Start Date: June 2010
Study Completion Date: April 25, 2017
Primary Completion Date: April 25, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

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: April 27, 2017

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 May 23, 2017