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

April 27, 2017 updated by: Philip Wai Yan CHIU, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: POEM
Per Oral Endoscopic Myotomy
Procedure: Per Oral Endoscopic Myotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dysphagia score before and after P.O.E.M.
Time Frame: From 1st day after POEM to within 2 weeks after POEM
From 1st day after POEM to within 2 weeks after POEM

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

April 25, 2017

Study Completion (ACTUAL)

April 25, 2017

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (ESTIMATE)

February 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2010_430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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