Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: July 2010
Last updated: February 1, 2012
|