Outcomes of Short-length vs Standard-length Myotomy Using Per-Oral Endoscopic Myotomy (POEM) for Achalasia: A Randomized Controlled Pilot Study
Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Illinois
Northwestern Memorial Hospital
Chicago
Time Frame
Start Date: 2020-06-01
Completion Date: 2024-02-29
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Standard Length Myotomy
Patients randomized to received 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
Experimental: Short Length Myotomy
Patients randomized to received 4 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
Related Therapeutic Areas
Sponsors
Leads: Northwestern University