NCT01873300

Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

Endoscopic Esophageal Myotomy for the Treatment of Achalasia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Detailed description

The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia. Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing. Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach. Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy. Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions. The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it works. Additionally, the researchers will assess the level of pain and the amount of scarring subjects has after this surgery.

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Esophageal Myotomy	Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-06-10
• Last updated: 2015-04-09

Locations

1 site across 1 country: United States