Back to resultsEndoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)
Primary Purpose
Achalasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Myotomy
Endoscopic Myotomy for treatment of achalasia
Sponsored by
About this trial
This is an interventional treatment trial for Achalasia focused on measuring Achalasia
Eligibility Criteria
Inclusion Criteria:
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
- Candidate for elective Heller myotomy
Exclusion Criteria:
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- BMI > 45
Sites / Locations
- The Oregon Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic Myotomy
Arm Description
Outcomes
Primary Outcome Measures
Improved quality of life as defined by survey pre and post surgery
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
Secondary Outcome Measures
Negative pH test
Patients will be required to have 24 hour pH testing after surgery.
Bleeding
recorded blood loss will be taken during surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01399476
Brief Title
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
Acronym
POEM
Official Title
Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Oregon Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.
Detailed Description
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Achalasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Myotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Myotomy
Other Intervention Name(s)
POEM
Intervention Description
Patients will receive the surgical procedure described in the summary (POEM).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Myotomy for treatment of achalasia
Other Intervention Name(s)
POEM
Intervention Description
Surgical procedure
Primary Outcome Measure Information:
Title
Improved quality of life as defined by survey pre and post surgery
Description
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Negative pH test
Description
Patients will be required to have 24 hour pH testing after surgery.
Time Frame
six months
Title
Bleeding
Description
recorded blood loss will be taken during surgery.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to undergo general anesthesia
Age > 18 yrs. of age and < 85 yrs. of age
Ability to give informed consent
Candidate for elective Heller myotomy
Exclusion Criteria:
Previous mediastinal or esophageal surgery
Contraindications for esophagogastroduodenoscopy
BMI > 45
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee L Swanstrom, MD
Organizational Affiliation
The Oregon Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23394838
Citation
Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanstrom LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.
Results Reference
derived
Learn more about this trial
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
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