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

Achalasia 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: Completed

Administrative data

• NCT number: NCT01525732
• Other study ID #: CRE-2010_430
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: April 27, 2017
• Start date: June 2010
• Est. completion date: April 25, 2017

Study information

• Verified date: April 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 50
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia
• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Hypertensive LES

Intervention

Procedure:
• Per Oral Endoscopic Myotomy

Locations

Country	Name	City	State
Hong Kong	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 before and after P.O.E.M.		From 1st day after POEM to within 2 weeks after POEM
Secondary	Eckardt score before and after P.O.E.M.		Before and 1 month after POEM
Secondary	Post-operative pain		From Day 1 to until 2 weeks after POEM
Secondary	Operative time		Up to 24 hours
Secondary	Hospital stay		From day of admission till up to 30 days
Secondary	Perioperative complication		30 days after operation