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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01524471
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Procedure: Per Oral Endoscopic Myotomy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: POEM Endoscopic Myotomy	Procedure: Per Oral Endoscopic Myotomy

Outcome Measures

Primary Outcome Measures

1. Dysphagia score []

Secondary Outcome Measures

1. Improvement in LES pressure []

2. Eckhart score []

3. Operative time []

4. Length of myotomy []

5. Time to resume diet []

6. Morbidities []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Chinese University of Hong Kong	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01524471
• Other Study ID Numbers: CRE_2010.430
• First Posted: Feb 2, 2012
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by , ,: Hypertensive LES
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Feb 2, 2012