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

NCT01524458 | Unknown Phase 1

• 1 other identifier: CRE-2010.430
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relief of Dysphagia

  4 weeks

Secondary Outcomes (1)

• Complication

  30 days

Study Arms (1)

POEM

EXPERIMENTAL

To perform myotomy using endoscopy through a long submucosal tunnel

Procedure: Per-Oral Endoscopic Myotomy

Interventions

Per-Oral Endoscopic Myotomy PROCEDURE

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

POEM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Informed consent not available
• Previous history of esophagectomy or mediastinal surgery
• Previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
• End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

Study Officials

• Philip WY Chiu, MD

  Dept of Surgery, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip WY Chiu, MD

CONTACT

85226322627; philipchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 2, 2012
• Study Start: July 1, 2010
• Last Updated: February 2, 2012

Record last verified: 2010-10

Locations

CN (1)