Status:
COMPLETED
Short Vs Standard Length Myotomy in Achalasia
Lead Sponsor:
Northwestern University
Conditions:
Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy ...
Detailed Description
BACKGROUND: Achalasia is a disorder of esophageal dysmotility characterized by dysfunctional peristalsis and increased lower esophageal sphincter (LES) tone. Achalasia is further divided into three s...
Eligibility Criteria
Inclusion
- All patients aged 18+ diagnosed with Type I or Type II achalasia, and patients with EGJ Outflow Obstruction with features of achalasia based on HRM or Endoscopic Functional Lumen Imaging Probe (EndoFLIP)
- All subjects must have given signed, informed consent prior to registration in the study
Exclusion
- Patient with Type III achalasia or spastic esophageal dysmotility disorders requiring long myotomy as determined by HRM
- All patients who are unable or unwilling to give consent will not be included in the study
- Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 50,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
- Patients who have already undergone treatment with POEM or Heller Myotomy
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04798547
Start Date
June 1 2020
End Date
February 29 2024
Last Update
March 15 2024
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611