Clinical Trial

To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage

Study acronym: STEP1
Recruiting
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Summary
In adults with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound (EUS)-guided transluminal necrosectomy, does early removal of the lumen-apposing metal stent (LAMS) (at 2 weeks or immediately after the last necrosectomy) with placement of a double-pigtail plastic stent (DPT), compared to delayed LAMS removal at 4 weeks without a DPT, result in a lower rate of pancreatic fluid collection (PFC) recurrence or need for reintervention over 12 months.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-12-13; most recent amendment 2026-01-27.
Status change: Not Yet Recruiting → Recruiting 2026-01-11
Trial Details
NCT Number NCT07307248
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions Walled Off Necrosis
Enrollment 408 participants
Start Date 2025-12-25
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-28