T Vuorela1, Harri Mustonen2, Arto Kokkola2, Caj Haglund2, Hanna Seppänen2. 1. Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: tiina.a.vuorela@hus.fi. 2. Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Abstract
OBJECTIVES: Post-operative pancreatic fistula (POPF) is a feared complication after a pancreaticoduodenectomy. Previously in a randomized trial found fewer clinically relevant fistulas (CR-POPF) accompanying administration of perioperative pasireotide. Our hospital previously found that the risk for CR-POPF reached 7% in pancreaticoduodenectomy patients. Here, we aimed to determine the CR-POPF rate accompanying prophylactic pasireotide in patients with a normal pancreas at resection level. METHODS: In this clinical study, perioperative pasireotide was administered to pancreaticoduodenectomy patients treated between 1 July 2014 and 30 April 2016. High-risk individuals were defined preoperatively by the surgeon based on the following: no dilatation of the pancreatic duct, suspected soft pancreas and a cystic or neuroendocrine tumor at the head of the pancreas. If the pancreas was considered hard at surgery, thereby carrying a lower risk for fistula, pasireotide was discontinued following one preoperative 900-μg dose. Among high-risk patients, pasireotide was continued for one week or until discharge from the hospital. RESULTS: During the study period, 153/215 pancreatic operations were pancreaticoduodenectomies, 58 (38%) of which were considered high risk for developing clinically significant pancreatic fistula. Among these, 4 (2.6%) developed a grade B or C fistula: 2 in the pasireotide group [3.5%, 95% confidence interval (CI) 0.4-11.9%], 1 in the low-risk group (1.2%, 95% CI 0.0-6.4%; difference: 2.3%, 95% CI -6.4-17.3%) and 1 in the discontinued group (10%). CONCLUSION: We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.
OBJECTIVES: Post-operative pancreatic fistula (POPF) is a feared complication after a pancreaticoduodenectomy. Previously in a randomized trial found fewer clinically relevant fistulas (CR-POPF) accompanying administration of perioperative pasireotide. Our hospital previously found that the risk for CR-POPF reached 7% in pancreaticoduodenectomy patients. Here, we aimed to determine the CR-POPF rate accompanying prophylactic pasireotide in patients with a normal pancreas at resection level. METHODS: In this clinical study, perioperative pasireotide was administered to pancreaticoduodenectomy patients treated between 1 July 2014 and 30 April 2016. High-risk individuals were defined preoperatively by the surgeon based on the following: no dilatation of the pancreatic duct, suspected soft pancreas and a cystic or neuroendocrine tumor at the head of the pancreas. If the pancreas was considered hard at surgery, thereby carrying a lower risk for fistula, pasireotide was discontinued following one preoperative 900-μg dose. Among high-risk patients, pasireotide was continued for one week or until discharge from the hospital. RESULTS: During the study period, 153/215 pancreatic operations were pancreaticoduodenectomies, 58 (38%) of which were considered high risk for developing clinically significant pancreatic fistula. Among these, 4 (2.6%) developed a grade B or C fistula: 2 in the pasireotide group [3.5%, 95% confidence interval (CI) 0.4-11.9%], 1 in the low-risk group (1.2%, 95% CI 0.0-6.4%; difference: 2.3%, 95% CI -6.4-17.3%) and 1 in the discontinued group (10%). CONCLUSION: We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.