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

Phase 1

• Conditions: Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES
• Interventions: Procedure: Per-Oral Endoscopic Myotomy

• Registration Number: NCT01524458
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES). Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary esophageal motility disorder in which the LES failed to relax with increased pressure. Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-10
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Study First Posted: 2012-02-02
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• All patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

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Exclusion Criteria

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, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POEM	Per-Oral Endoscopic Myotomy	To perform myotomy using endoscopy through a long submucosal tunnel

Primary Outcome Measures

Name	Time	Method
Relief of Dysphagia	4 weeks

Secondary Outcome Measures

Name	Time	Method
Complication	30 days

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China