Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy

PRIMARY OBJECTIVE: I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF. SECONDARY OBJECTIVES: I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi. II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF. EXPLORATORY OBJECTIVES: I. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in POPF. II. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in clinically relevant POPF (crPOPF). III. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in postoperative length of hospital stay. IV. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of Clavien-Dindo grade III or greater complications. V. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of percutaneous drainage. VI. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of unplanned re-operation. OUTLINE: Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. Patients are followed for 30 days following distal pancreas resection.