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

Phase 1

Completed

• Conditions: Achalasia
• Interventions: Procedure: Endoscopic Esophageal Myotomy

• Registration Number: NCT01873300
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Diagnosis of achalasia
• Age 18-65
• ASA class 1-2

Exclusion Criteria

• Pregnant women
• Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
• Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
• ASA class III patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Endoscopic Esophageal Myotomy	Patients undergoing POEM procedure

Primary Outcome Measures

Name	Time	Method
Improvement of quality of life and dysphagia symptoms	6 months	Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery

Trial Locations

Locations (1)

Masschusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States