Early Versus Standard Plastic Stent Replacement After Metal Stent Removal to Prevent Recurrence of Pancreatic Fluid Collections This Trial Compares Early (2-week) Versus Standard (4-week) Plastic Stent Replacement After Metal Stent Removal in Walled-off Necrosis to
NCT ID: NCT07307248
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
408 participants
INTERVENTIONAL
2025-12-25
2028-12-31
Brief Summary
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Detailed Description
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Prolonged retention of LAMS has been associated with several adverse events, including delayed bleeding due to vascular erosion, buried-stent syndrome, stent migration, and tissue hyperplasia at the tract site. Conversely, premature removal of the stent may lead to incomplete drainage, persistent or recurrent pancreatic fluid collections (PFCs), and the need for repeat interventions. Therefore, determining the ideal balance between minimizing stent-related complications and preventing recurrence is a key clinical challenge.
Early removal of the LAMS-either 2 weeks after insertion or immediately after the last necrosectomy session-may reduce the risk of delayed bleeding and other metal stent-related complications. However, to maintain tract patency and allow residual drainage, placement of a prophylactic double-pigtail plastic stent (DPT) at the time of LAMS removal has been proposed. The DPT provides a smaller but stable drainage channel that may prevent premature tract closure and recurrence of fluid collections.
This randomized controlled trial aims to rigorously test whether early LAMS removal combined with DPT placement offers better long-term outcomes compared to standard 4-week LAMS removal without DPT. The results are expected to provide evidence-based guidance on optimizing stent management in patients with WON undergoing endoscopic necrosectomy, balancing efficacy with safety.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement)
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.
Standard LAMS Removal with Double-Pigtail Plastic Stent
In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).
Standard Stent Replacement Arm (4-Week LAMS Removal without DPT)
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.
Standard LAMS Removal without DPT
In the standard arm, LAMS will be removed at 4 weeks.
Interventions
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Standard LAMS Removal with Double-Pigtail Plastic Stent
In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).
Standard LAMS Removal without DPT
In the standard arm, LAMS will be removed at 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Senior Registrar
Principal Investigators
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Deepak L Jha, (Medical Gastroenterology)
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology, Hyderabad
Locations
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Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Countries
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Central Contacts
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Deepak L JHA, DrNB( medical gastroenterology
Role: CONTACT
Phone: 91-9967807858
Email: [email protected]
Nitin G Jagtap, DNB (Medical Gastroenterology)
Role: CONTACT
Phone: +91-82859523
Email: [email protected]
Facility Contacts
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Deepak L JHA, Medical Gastroenterology
Role: primary
Nitin G Jagtap, Medical Gastroenterology)
Role: backup
References
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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.
Other Identifiers
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STEP 1
Identifier Type: -
Identifier Source: org_study_id