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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Achalasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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POEM

Endoscopic Myotomy

Group Type EXPERIMENTAL

Per Oral Endoscopic Myotomy

Intervention Type PROCEDURE

Interventions

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Per Oral Endoscopic Myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No