Lanreotide for the Prevention of Postoperative Pancreatic Fistula: Phase Ii Clinical Trial Results

Introduction: Clinically significant pancreatic fistula (CSPF) rate, which is the major cause of postoperative morbidity and mortality following pancreatic resection, in high volume centers is reported to be as high as 45%. We previously published a CSPF rate of 27% for pancreaticoduodenectomy (PD). We hypothesized that Lanreotide, a long-acting somatostatin analogue, would decrease CSPF. Methods: We conducted a single-center, phase II trial of preoperative, single-dose Lanreotide in patients undergoing either PD or distal pancreatectomy (DP). Enrolled subjects received a subcutaneous injection of 120 mg Lanreotide immediately prior to their operation. The primary outcome was development of CSPF or intra-abdominal abscess. The secondary outcomes included biochemical PF, major and overall complications. Subjects were followed up for 60 postoperative days. Results: A total of 114 patients who were candidates for PD or DP for confirmed or suspected malignancy were enrolled in the study. Sixteen subjects were excluded or withdrew, 98 completed the study. Sixty-two subjects underwent PD and 36 underwent DP. Mean age was 64 years. Thirty-five subjects were females. The study’s primary outcome was observed in eight subjects in the overall cohort, one from the DP group and seven from the PD group. Biochemical PF was detected in a total of 12 subjects. Fourteen subjects developed major complications. Drug related adverse events were limited to mild skin reactions in two subjects. Conclusion: Our study shows promising clinical efficacy for preoperative Lanreotide in patients undergoing pancreatic resection. These data strongly call for a randomized controlled trial to confirm our findings. Tabled 1EP02D-139 1Operative CharacteristicsPancreaticoduodenectomy (n=62)Distal Pancreatectomy (n=36)Total (n=98)Pancreatic Gland Texture (soft)n21 (34%)21 (58%)42 (43%)Pancreatic Duct Size (≤4)n41 (66%)27 (75%)68 (69%)Estimated Blood Loss (ml)median (IQR)150 (71-300)22 (10-93)100 (47-212)PathologyPDA: Other38:2418:1856:42Postoperative OutcomesPrimary Outcome (Abscess + Grade B/C POPF)n7 (11.2%)1 (2.7%)8 (8.2%)Secondary Outcome (Biochemical PF)n3 (4.8%)9 (25%)12 (12.2%)Secondary Outcome (Major Complication)n11 (17.7%)3 (8.3%)14 (14.2%)Secondary Outcome (Overall Complication)n16 (26%)11 (30%)27 (27.5%) Open table in a new tab