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

Condition(s) targeted: Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES

Intervention: Per-Oral Endoscopic Myotomy (Procedure)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
Philip WY Chiu, MD, Principal Investigator, Affiliation: Dept of Surgery, The Chinese University of Hong Kong

Overall contact:
Philip WY Chiu, MD, Phone: 85226322627, Email: philipchiu@surgery.cuhk.edu.hk

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.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Relief of Dysphagia

Secondary outcome: Complication

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Philip WY Chiu, MD, Phone: 85226322627, Email: philipchiu@surgery.cuhk.edu.hk

Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; Recruiting
Philip WY Chiu, M, Phone: 85226322627, Email: philipchiu@surgery.cuhk.edu.hk
Philip WY Chiu, MD, Principal Investigator

Starting date: July 2010
Last updated: February 1, 2012