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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
David W. Rattner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01873300
First received: June 5, 2013
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Achalasia
Procedure: Endoscopic Esophageal Myotomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Esophageal Myotomy for the Treatment of Achalasia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Improvement of quality of life and dysphagia symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery


Estimated Enrollment: 5
Study Start Date: February 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment group
Patients undergoing POEM procedure
Procedure: Endoscopic Esophageal Myotomy
Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.
Other Names:
  • POEM
  • Trans-esophageal endoscopic myotomy
  • Per-oral endoscopic myotomy
  • Endoscopic Heller Myotomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873300

Contacts
Contact: Deborah J McGrath, RN 617-724-4091 DMCGRATH@PARTNERS.ORG

Locations
United States, Massachusetts
Masschusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ozanan R Meireles, MD       Omeireles@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David W Rattner, MD Massachusetts General Hospital
Study Director: Ozanan R Meireles, MD Masschusetts General Hospital / Harvard Medical School
  More Information

Publications:
Responsible Party: David W. Rattner, MD, Professor of Surgery - Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01873300     History of Changes
Other Study ID Numbers: 2011P001806
Study First Received: June 5, 2013
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Achalasia
Dysphagia
Endoscopic
Myotomy
Heller
NOTES
POEM

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 15, 2014