Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial

The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.

The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.

Inclusion Criteria:

1. Patients undergoing a pancreatoduodenectomy
2. Patients aged 18 or above
3. Patients who have given an informed consent

Exclusion Criteria:

1. Patients who do not or cannot give an informed consent.
2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
3. Patients undergoing active immunosuppressive therapy.