The value of drains as a fistula mitigation strategy for pancreatoduodenectomy: something for everyone? Results of a randomized prospective multi-institutional study.

BACKGROUND: A recent randomized, controlled trial investigating intraperitoneal drain use during pancreatoduodenectomy (PD) had a primary goal of assessing overall morbidity. It was terminated early with findings that routine elimination of drains in PD increases mortality and the severity and frequency of overall complications. Here, we provide a follow-up analysis of drain value in reference to clinically relevant postoperative pancreatic fistula (CR-POPF). METHODS: Nine institutions performed 137 PDs, with patients randomized to intraperitoneal drainage (N = 68) or no drainage (N = 69). The Fistula Risk Score (FRS), a 10-point scale derived from four validated risk factors for CR-POPF, facilitated risk adjustment between treatment groups. RESULTS: There was no difference in fistula risk between the two cohorts. Overall, CR-POPF rates were higher in the no drain group compared to the drain group (20.3 vs. 13.2%; p = 0.269). Patients with negligible/low FRS risk had higher rates of CR-POPF when drains were used (14.8 vs. 4.0%; p = 0.352). Conversely, there were significantly fewer CR-POPFs (12.2 vs. 29.5%; p = 0.050) when drains were used with moderate/high risk patients. Lastly, moderate/high risk patients who suffered a CR-POPF had reduced 90-day mortality (22.2 vs. 42.9%) when a drain was used. CONCLUSION: The results of this analysis suggest that drains diminish the rate and severity of CR-POPF in patients with moderate/high risk, but they could possibly be avoided in the roughly one third of patients with negligible/low risk.