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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Unknown
Phase 2

Conditions

Achalasia

Treatments

Procedure: Per Oral Endoscopic Myotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01524471
CRE_2010.430

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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 Investigations before and after POEM

Trial design

20 participants in 1 patient group

POEM
Experimental group
Description:
Endoscopic Myotomy
Treatment:
Procedure: Per Oral Endoscopic Myotomy

Trial contacts and locations

1

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Central trial contact

Philip WY Chiu, MD

Data sourced from clinicaltrials.gov

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