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

NCT ID: NCT01524458

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

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.

Conditions

Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POEM

To perform myotomy using endoscopy through a long submucosal tunnel

Group Type: EXPERIMENTAL

Per-Oral Endoscopic Myotomy

Intervention Type: PROCEDURE

To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel

Interventions

Per-Oral Endoscopic Myotomy

To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Principal Investigators

Philip WY Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Surgery, The Chinese University of Hong Kong

Locations

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Philip WY Chiu, MD

Role: CONTACT

philipchiu@surgery.cuhk.edu.hk

85226322627

Facility Contacts

Philip WY Chiu, M

Role: primary

philipchiu@surgery.cuhk.edu.hk

85226322627

Other Identifiers

CRE-2010.430

Identifier Type: -

Identifier Source: org_study_id