Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

Achalasia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524471
• Other study ID #: CRE_2010.430
• Status: Recruiting
• Phase: Phase 2
• First received: February 1, 2012
• Last updated: February 1, 2012
• Start date: July 2010

Study information

• Verified date: January 2012
• Source: Chinese University of Hong Kong
• Contact: Philip WY Chiu, MD
• Phone: 26322627
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients with age ranged 18 to 80 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:

• Patients will be excluded from this study with the followings -

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, including endoscopic mucosal resection and endoscopic submucosal dissection

5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM

Study Design

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse

Intervention

Procedure:
• Per Oral Endoscopic Myotomy

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia score			No
Secondary	Improvement in LES pressure
Secondary	Eckhart score
Secondary	Operative time
Secondary	Length of myotomy
Secondary	Time to resume diet
Secondary	Morbidities