POEM: Personalized Peroral Endoscopic Myotomy for Achalasia

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT01570621

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

Condition or Disease	Intervention/Treatment	Phase
Achalasia Postoperative Complications	Procedure: peroral endoscopic myotomy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Personalized Peroral Endoscopic Myotomy for Achalasia

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Outcome Measures

Primary Outcome Measures

symptom relief [1-12months]
compare patients' symptoms before and after POEM at 1 month, 12 months.
Lower esophageal sphincter pressure [1-12months]
compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
improvement of esophageal barium [1-12 months]
compare esophageal barium before and after POEM at 1 months,12 months
Postoperative complications [0-12months]
postoperative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
Age over 18 years old
Signed written informed consent