Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
NCT ID: NCT05668260
Last Updated: 2025-03-14
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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RECRUITING
NA
122 participants
INTERVENTIONAL
2023-01-25
2026-09-30
Brief Summary
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Patients undergoing PD will be randomized into two arms:
* arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis
* arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis
The rate of occurrence of CR-POPF will be compared between the two arms.
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Detailed Description
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In this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing PD versus no stenting, focusing on a possible superiority association for preventing CR-POPF.
Participants will be randomised into two arms (Biodegradable stent vs non-stent) based on their intra-operative risk of developing POPF according to the Fistula Risk Score (FRS). The rate of CR-POPF will be compared between the two arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Biodegradable Stent
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Biodegradable Stent
A trans-anastomotic biodegradable internal stent (ARCHIMEDES™) will be placed between the main pancreatic duct (MPD) and the enterotomy in the jejunum just after the completion of the posterior suture of duct-to-mucosa. The biodegradable stent will then be shaped according to the angle of the jejunal loop in order to minimise the risk of displacement. The adequate length of the stent will be chosen according to the length of the jejunal loop.
Non Stent
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
No interventions assigned to this group
Interventions
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Biodegradable Stent
A trans-anastomotic biodegradable internal stent (ARCHIMEDES™) will be placed between the main pancreatic duct (MPD) and the enterotomy in the jejunum just after the completion of the posterior suture of duct-to-mucosa. The biodegradable stent will then be shaped according to the angle of the jejunal loop in order to minimise the risk of displacement. The adequate length of the stent will be chosen according to the length of the jejunal loop.
Eligibility Criteria
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Inclusion Criteria
* Patients who undergo pancreatoduodenectomy (PD)
* Informed Consent
Exclusion Criteria
* Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \< 7)
18 Years
ALL
No
Sponsors
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amg International
UNKNOWN
Ospedale San Raffaele
OTHER
Responsible Party
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Stefano Partelli
Professor
Locations
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IRCCS Ospedale San Raffaele
Milan, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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BioSteP
Identifier Type: -
Identifier Source: org_study_id
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