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Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

NCT01560559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-05-25

No results posted yet for this study

Summary

Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

Conditions

  • Primary Achalasia

Interventions

PROCEDURE

Peroral endoscopic myotomy

An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1. This is a study of a procedure - peroral endoscopic myotomy (POEM). No new, unapproved device is used. All endoscopic tools are already approved for endoscopic submucosal dissection and associated complications (hemorrhage or perforation): dissection knifes, hot biopsy forceps, endoscopic metallic clips.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Thierry PONCHON, Pr · Hospices Civiles de Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560559 on ClinicalTrials.gov