Clinical Trial

Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

Recruiting
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Record status
This record was last updated June 10, 2025 (before its estimated June 14, 2025 completion). Its status may not reflect the trial's current state.
Summary
\- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-06; most recent amendment 2025-06-09.
Trial Details
NCT Number NCT06870630
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions Esophageal Diseases
Enrollment 158 participants
Start Date 2023-11-29
Primary Completion 2025-06-14 (estimated)
Study Completion 2025-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-10