Personalized Peroral Endoscopic Myotomy for Achalasia (POEM)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

ClinicalTrials.gov Identifier:

NCT01570621

First received: April 1, 2012

Last updated: April 3, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2012

Last Updated Date

April 3, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

symptom relief [ Time Frame: 1-12months ] [ Designated as safety issue: No ]
compare patients' symptoms before and after POEM at 1 month, 12 months.
Lower esophageal sphincter pressure [ Time Frame: 1-12months ] [ Designated as safety issue: No ]
compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
improvement of esophageal barium [ Time Frame: 1-12 months ] [ Designated as safety issue: No ]
compare esophageal barium before and after POEM at 1 months,12 months
Postoperative complications [ Time Frame: 0-12months ] [ Designated as safety issue: Yes ]
postoperative complications

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01570621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Personalized Peroral Endoscopic Myotomy for Achalasia

Official Title ^ICMJE

Personalized Peroral Endoscopic Myotomy for Achalasia

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Achalasia
Postoperative Complications

Intervention ^ICMJE

Procedure: peroral endoscopic myotomy

A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Patients with previous surgery of the stomach or esophagus
With known coagulopathy
Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
Pregnancy
Stricture of the esophagus
Hiatal hernia > 2cm

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01570621

Other Study ID Numbers ^ICMJE

DrumTower206-01

Has Data Monitoring Committee

Yes

Responsible Party

Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Sponsor ^ICMJE

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tingsheng Ling

Nanjing Drum Tower Hospital

Information Provided By

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top