Somatostatin Prevents Clinically Relevant Pancreatic Fistula in Intermediate Risk Patients after Pancreaticoduodenectomy (SPEED): A Multi-center, Randomized, Controlled Study

Introduction: Post-operative pancreatic fistula (POPF) remains the lethal complication after pancreaticoduodenectomy, and the objective of the study is evaluating the preventive effect of somatostatin on POPF in intermediate risk patients. Methods: A multi-center, randomized, controlled study was conducted in six high-volume pancreas centers in China between June 2018 and April 2019. Patients undergoing pancreaticoduodenectomy with intermediate risk of POPF were enrolled. Patients were randomly assigned to somatostatin group (intravenous somatostatin of 250μg/h for 120 hours) and control group. The primary endpoint was clinically relevant POPF (CR-POPF) (according to 2016 International Study Group on Pancreatic Fistula criteria). This trial was registered with Clinical Trial (NCT03349424). Results: 205 patients were enrolled and 99 in somatostatin group and 100 in control group were included for final analysis. The rate of CR-POPF in somatostatin group decreased significantly (13% vs 25%, p=0.032), both in open and laparoscopic pancreaticoduodenectomy. But the rates of overall POPF (65% vs 69%, p=0.51) and biochemical leak (52% vs 44%, p=0.29) were not significantly different. Medical costs (¥115069 vs ¥115803, p=0.92) and other complications: biliary fistula (6% vs 6%, p=0.99), abdominal infection (19% vs 18%, p=0.83), chylous fistula (5% vs 4%, p=0.75), late postoperative hemorrhage (7% vs 12%, p=0.24) had no significant difference. However, the somatostatin group had higher rate of delayed gastric emptying (33% vs 21%, p=0.0504). Conclusion: In patients with intermediate risk of POPF after pancreaticoduodenectomy, prophylactic use of somatostatin can reduce the CR-POPF, but seems to increase the rate of delayed gastric emptying.OP04-19The baseline characteristics of study participantsOverall (n=199)somatostatin group (n=99)control group (n=100)Age, mean (SD), yrs58.857.92 (11.4)59.18 (10.7)Male sex123(62%)57 (57%)66 (66%)BMI, mean (SD) (kg/m2)22.922.58 (3.2)23.26 (3.2)Hypertension inmedical history56(28%)56(28%)32 (32%)Diabetes mellitus in medical history33(17%)16 (16%)17 (17%)Chronic pancreatitis in medical history2(1%)2 (2%)0(0%)Acute pancreatitis in medical history5(3%)0(0%)5 (5%) Open table in a new tab