STEP1
A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.
Sponsor study identifier
interventional
408
1 country
1
Study Start
December 25, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2025
Actual (reported)December 25, 2025
Actual (reported)December 29, 2025
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recurrence of Pancreatic Fluid Collection (PFC)
Recurrence is defined as the redevelopment of a symptomatic pancreatic fluid collection confirmed on imaging (CT or MRI) after initial resolution following endoscopic drainage and lumen-apposing metal stent (LAMS) removal. The recurrence rate will be compared between the early LAMS removal + double-pigtail plastic stent (DPT) group and the standard 4-week LAMS removal group.
12 months after initial drainage procedure
Recurrence of Pancreatic Fluid Collection at 3 and 6 Months
3 months and 6 months after the initial drainage procedure
Stent-Related Adverse Events
Up to 12 months post-procedure
Need for Reinterventions
Within 12 months after stent removal
Participants in this arm will undergo early removal of the lumen-apposing metal stent (LAMS) at 2 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Following LAMS removal, a double-pigtail plastic stent (DPT) will be placed across the transmural tract to maintain drainage and reduce the risk of recurrent pancreatic fluid collection (PFC). Patients will undergo follow-up imaging at 3, 6, and 12 months to assess recurrence, complications, and need for reintervention.
Participants in this arm will undergo standard removal of the LAMS at 4 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Patients will be followed at 3, 6, and 12 months to assess recurrence of pancreatic fluid collection (PFC), complications, and reintervention rates.
In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).
In the standard arm, LAMS will be removed at 4 weeks.
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082, India
Zeng Y, Yang J, Zhang JW. Endoscopic transluminal drainage and necrosectomy for infected necrotizing pancreatitis: Progress and challenges. World J Clin Cases. 2023 Mar 26;11(9):1888-1902. doi: 10.12998/wjcc.v11.i9.1888.
Deepak L Jha, (Medical Gastroenterology)
Asian Institute of Gastroenterology, Hyderabad
First Submitted
December 13, 2025
First Posted
December 29, 2025
Study Start
December 25, 2025
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 28, 2026
Record last verified: 2026-01
Individual participant data (IPD) will not be shared because data sharing is not planned for this study.
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Source: ClinicalTrials.gov.
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