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

Primary Purpose

Achalasia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Esophageal Myotomy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Achalasia, Dysphagia, Endoscopic, Myotomy, Heller, NOTES, POEM

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masschusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

Patients undergoing POEM procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 5, 2013
Last Updated
April 8, 2015
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01873300
Brief Title
Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure
Acronym
POEM
Official Title
Endoscopic Esophageal Myotomy for the Treatment of Achalasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Achalasia, Dysphagia, Endoscopic, Myotomy, Heller, NOTES, POEM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients undergoing POEM procedure
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Esophageal Myotomy
Other Intervention Name(s)
POEM, Trans-esophageal endoscopic myotomy, Per-oral endoscopic myotomy, Endoscopic Heller Myotomy
Intervention Description
Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.
Primary Outcome Measure Information:
Title
Improvement of quality of life and dysphagia symptoms
Description
Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Rattner, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozanan R Meireles, MD
Organizational Affiliation
Masschusetts General Hospital / Harvard Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Masschusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20845759
Citation
Inoue H, Kudo SE. [Per-oral endoscopic myotomy (POEM) for 43 consecutive cases of esophageal achalasia]. Nihon Rinsho. 2010 Sep;68(9):1749-52. Japanese.
Results Reference
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PubMed Identifier
22040634
Citation
Inoue H, Tianle KM, Ikeda H, Hosoya T, Onimaru M, Yoshida A, Minami H, Kudo SE. Peroral endoscopic myotomy for esophageal achalasia: technique, indication, and outcomes. Thorac Surg Clin. 2011 Nov;21(4):519-25. doi: 10.1016/j.thorsurg.2011.08.005.
Results Reference
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PubMed Identifier
22068665
Citation
von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
Results Reference
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Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

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