Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
Ospedale San Raffaele
122 participants
Jan 25, 2023
INTERVENTIONAL
Conditions
Summary
The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). 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.
Eligibility
Inclusion Criteria3
- Age ≥18
- Patients who undergo pancreatoduodenectomy (PD)
- Informed Consent
Exclusion Criteria2
- Previous distal pancreatectomy
- Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score < 7)
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Interventions
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.
Locations(1)
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NCT05668260