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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:
ClinicalTrials.gov Identifier:
NCT01525732
First Posted: February 3, 2012
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philip Wai Yan Chiu, Chinese University of Hong Kong
  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: None (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:


Further study details as provided by Philip Wai Yan Chiu, 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 1, 2012
First Posted: February 3, 2012
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Philip Wai Yan Chiu, 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