Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

PHASE3CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

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."

Trial Locations (1)

69003

Clinique de Hépatogastroentérologie, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01560559 - Peroral Endoscopic Myotomy for Primary Esophageal Achalasia | Biotech Hunter | Biotech Hunter