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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01525732
Acronym
POEM
Enrollment
50
Registered
2012-02-03
Start date
2010-06-30
Completion date
2017-04-25
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Hypertensive LES

Keywords

Achalasia, Hypertensive LES

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.

Interventions

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dysphagia score before and after P.O.E.M.From 1st day after POEM to within 2 weeks after POEM

Secondary

MeasureTime frame
Eckardt score before and after P.O.E.M.Before and 1 month after POEM
Post-operative painFrom Day 1 to until 2 weeks after POEM
Operative timeUp to 24 hours
Hospital stayFrom day of admission till up to 30 days
Perioperative complication30 days after operation

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026