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

Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES Clinical Trial

— POEM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524458
• Other study ID #: CRE-2010.430
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 1, 2012
• Last updated: February 1, 2012
• Start date: July 2010

Study information

• Verified date: October 2010
• Source: Chinese University of Hong Kong
• Contact: Philip WY Chiu, MD
• Phone: 85226322627
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: The Chinese University of Hong Kong
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES

Intervention

Procedure:
• Per-Oral Endoscopic Myotomy
To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of Dysphagia		4 weeks	No
Secondary	Complication		30 days	Yes