Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders
POEM
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedMay 1, 2017
April 1, 2017
6.9 years
February 1, 2012
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dysphagia score before and after P.O.E.M.
From 1st day after POEM to within 2 weeks after POEM
Secondary Outcomes (5)
Eckardt score before and after P.O.E.M.
Before and 1 month after POEM
Post-operative pain
From Day 1 to until 2 weeks after POEM
Operative time
Up to 24 hours
Hospital stay
From day of admission till up to 30 days
Perioperative complication
30 days after operation
Study Arms (1)
POEM
OTHERPer Oral Endoscopic Myotomy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
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.
PMID: 23043852DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 3, 2012
Study Start
June 1, 2010
Primary Completion
April 25, 2017
Study Completion
April 25, 2017
Last Updated
May 1, 2017
Record last verified: 2017-04