Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy.

BACKGROUND: Postoperative pancreatic fistula (POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula (BF) or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place. METHODS: In this single-center study, we assessed patients who underwent elective PD from January 2014 to December 2017. Patients were divided into two groups: standard PD (ST-PD) vs. PD with external biliary stent (PD-BS). Demographic, preoperative, intraoperative, and postoperative variables were analyzed, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation. RESULTS: A total of 128 patients were included (65 in ST-PD group and 63 in PD-BS group). Postoperative complications occurred in 61.7% of patients (32.8%, Clavien-Dindo ≥ III) and were more common among patients in the PD-BS group (44.4% vs. 23.1%; p = 0.03). POPF was also more common among patients in the PD-BS group (39.7% vs. 18.5%; p = 0.008). No statistically significant differences were found for any other complications. CONCLUSION: Based on the results of our study, placement of a transanastomotic external biliary stent does not reduce the rate of pancreatic or biliary fistulae, or their severity; in fact, POPF is more likely when biliary exteriorization is present. TRIAL REGISTRATION: NCT04654299.