Overview
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.
Description
Clinically relevant postoperative pancreatic fistula (CR-POPF) represents the most common complication that can occur after pancreatoduodenectomy (PD). CR-POPF is the main cause of morbidity after PD, being associated with a risk of mortality up to 60%. The placement of external or internal pancreatic stents after PD have been investigated as possible strategies for preventing the development of CR-POPF. However, device displacement has been reported as a common cause of pancreatic stents malfunction. Recently, a novel biodegradable pancreatic stent (ARCHIMEDES™) has been introduced. The device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of CR-POPF after PD.
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.
Eligibility
Inclusion Criteria:
- Age ≥18
- Patients who undergo pancreatoduodenectomy (PD)
- Informed Consent
Exclusion Criteria:
- Previous distal pancreatectomy
- Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score < 7)