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

Primary Purpose

Achalasia, Hypertensive LES

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Per Oral Endoscopic Myotomy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Achalasia, Hypertensive LES

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

POEM

Arm Description

Per Oral Endoscopic Myotomy

Outcomes

Primary Outcome Measures

Dysphagia score before and after P.O.E.M.

Secondary Outcome Measures

Eckardt score before and after P.O.E.M.
Post-operative pain
Operative time
Hospital stay
Perioperative complication

Full Information

First Posted
February 1, 2012
Last Updated
April 27, 2017
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01525732
Brief Title
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders
Acronym
POEM
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
April 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia, Hypertensive LES
Keywords
Achalasia, Hypertensive LES

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POEM
Arm Type
Other
Arm Description
Per Oral Endoscopic Myotomy
Intervention Type
Procedure
Intervention Name(s)
Per Oral Endoscopic Myotomy
Primary Outcome Measure Information:
Title
Dysphagia score before and after P.O.E.M.
Time Frame
From 1st day after POEM to within 2 weeks after POEM
Secondary Outcome Measure Information:
Title
Eckardt score before and after P.O.E.M.
Time Frame
Before and 1 month after POEM
Title
Post-operative pain
Time Frame
From Day 1 to until 2 weeks after POEM
Title
Operative time
Time Frame
Up to 24 hours
Title
Hospital stay
Time Frame
From day of admission till up to 30 days
Title
Perioperative complication
Time Frame
30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 - Pregnancy Informed consent not available Previous history of esophagectomy or mediastinal surgery Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
23043852
Citation
Chiu PW, Wu JC, Teoh AY, Chan Y, Wong SK, Liu SY, Yung MY, Lam CC, Sung JJ, Chan FK, Lau JY, Ng EK. Peroral endoscopic myotomy for treatment of achalasia: from bench to bedside (with video). Gastrointest Endosc. 2013 Jan;77(1):29-38. doi: 10.1016/j.gie.2012.08.018. Epub 2012 Oct 6.
Results Reference
derived

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

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