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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT01525732
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 82.8
• Patients Per Site Per Month: 0.6

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; Hypertensive LES	Procedure: Per Oral Endoscopic Myotomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2010
• Actual Primary Completion Date: Apr 25, 2017
• Actual Study Completion Date: Apr 25, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Dysphagia score before and after P.O.E.M. [From 1st day after POEM to within 2 weeks after POEM]

Secondary Outcome Measures

1. Eckardt score before and after P.O.E.M. [Before and 1 month after POEM]

2. Post-operative pain [From Day 1 to until 2 weeks after POEM]

3. Operative time [Up to 24 hours]

4. Hospital stay [From day of admission till up to 30 days]

5. Perioperative complication [30 days after operation]

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Wai Yan Chiu, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01525732
• Other Study ID Numbers: CRE-2010_430
• First Posted: Feb 3, 2012
• Last Update Posted: May 1, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Philip Wai Yan Chiu, Professor, Chinese University of Hong Kong: Achalasia, Hypertensive LES
• Additional relevant MeSH terms: Esophageal Achalasia; Esophageal Motility Disorders; Esophageal Spasm, Diffuse

Study Results

No Results Posted as of May 1, 2017