BACKGROUND/AIMS: This randomized, placebo-controlled trial was analyzed in order to compare different methods of somatostatin administration in postoperative pancreatic fistula (POPF) and other postoperative complications following pancreaticoduodenectomy (PD). METHODOLOGY: Patients were randomized to a control group (n=32) and an experimental group (n=35). The primary endpoint was the incidences of POPF and other postoperative complications. The definition of POPF was classified as described by the International Study Group of Pancreatic Surgery. In the experimental group, the initial somatostatin was infused 1 day before operation and continued for 7 days after surgery. RESULTS: The incidences of POPF did not show a significant difference between the 2 groups (11/30, 36.7% vs. 14/30, 46.7%; p>0.385). However, blood transfusion volume was 1.7±1.53U in the experimental group and 2.7±2.2U in the control group (p=0.034). Furthermore, the abdominal amylase concentration was significantly lower in the experimental group (p=0.038 and p=0.043, respectively) in both Postoperative Day (POD) 3 and POD 7. CONCLUSIONS: Preoperative prophylactic use of somatostatin cannot decrease the incidence of POPF and other complications after PD compared to postoperative use. However, the amylase concentration of the abdominal drainage and the blood transfusion volume seems to be decreased. Further experimental investigations are needed to estimate the value of preoperative use of somatostatin and clear the concrete mechanism.
RCT Entities:
BACKGROUND/AIMS: This randomized, placebo-controlled trial was analyzed in order to compare different methods of somatostatin administration in postoperative pancreatic fistula (POPF) and other postoperative complications following pancreaticoduodenectomy (PD). METHODOLOGY:Patients were randomized to a control group (n=32) and an experimental group (n=35). The primary endpoint was the incidences of POPF and other postoperative complications. The definition of POPF was classified as described by the International Study Group of Pancreatic Surgery. In the experimental group, the initial somatostatin was infused 1 day before operation and continued for 7 days after surgery. RESULTS: The incidences of POPF did not show a significant difference between the 2 groups (11/30, 36.7% vs. 14/30, 46.7%; p>0.385). However, blood transfusion volume was 1.7±1.53U in the experimental group and 2.7±2.2U in the control group (p=0.034). Furthermore, the abdominal amylase concentration was significantly lower in the experimental group (p=0.038 and p=0.043, respectively) in both Postoperative Day (POD) 3 and POD 7. CONCLUSIONS: Preoperative prophylactic use of somatostatin cannot decrease the incidence of POPF and other complications after PD compared to postoperative use. However, the amylase concentration of the abdominal drainage and the blood transfusion volume seems to be decreased. Further experimental investigations are needed to estimate the value of preoperative use of somatostatin and clear the concrete mechanism.