Intraoperative biodegradable stent placement to reduce complications after pancreatoduodenectomy – Interim results from a randomised clinical trial

INTRODUCTION: Postoperative pancreatic fistula (POPF) remains a major cause of morbidity after pancreatoduodenectomy (PD), with an incidence of more than 30% in patients with small pancreatic ducts. Evidence supporting preventive measures remains limited. Biodegradable stent placement across the pancreaticojejunostomy (PJ) may reduce the POPF. This study represents the first randomised controlled trial evaluating biodegradable stents in patients with high-risk pancreaticojejunostomies. METHODS: This single centre, patient- and assessor-blinded, randomised clinical trial included patients undergoing PD with a main pancreatic duct < 5 mm. Patients were randomised 1:1 to receive a fast-degrading (12-day) ARCHIMEDES biodegradable stent or no stent. The primary endpoint was Clinically relevant postoperative pancreatic fistula CR-POPF. Secondary outcomes included biliary leakage, major complications (Clavien-Dindo ≥ III), length of stay, readmission, and mortality. RESULTS: In this interim analysis, 50 patients were randomised (26 received a stent, 24 no-stent). Baseline characteristics including Fistula Risk Score (FRS) were comparable. Patients were mainly operated for malignancies. CR-POPF incidence was lower in stent-group compared to no-stent group. However, this difference was not significant (11,50% vs. 25%, p = 0,20). Biliary leakage and intraoperative blood loss were similar between groups. Two cases of mild, self-limiting postoperative pancreatitis occurred in the stent group. No 30- or 90-day mortality was observed. Median length of stay and readmission rates did not differ significantly. CONCLUSION: Interim results from the first blinded, randomised trial with a biodegradable stent, showed no significant reduction in CR-POPF, but a trend towards reducing them. Completing the inclusion and initiating larger multicentre trials are needed to clarify its clinical benefit.