Somatostatin vs Octreotide for Postoperative Pancreatic Fistula Prevention - A Prospective Randomized Controlled Study - A FRENCH 007 – ACHBT Study

Aim: To compare ISGPF grade B/C pancreatic fistula rates at 90 days after pancreatectomy in patients randomized between somatostatin versus octreotide. Methods: Patients without neoadjuvant therapy eligible for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP)were randomized 1:1 to IVSE somatostatin 6mg/d versus octreotide SC 100 μg x3/d for days postoperatively. Randomization was stratified by procedure (PD vs. DP) and size of the main pancreatic duct (< or ≥ 4 mm) Results: Of 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, comparable on the stratification criteria. Most patients had PD (n=480; 73.8%), on soft/normal pancreas (n=367; 63.2%) with a non-dilated main pancreatic duct (n=472; 72.5%), most often for adenocarcinoma (n=249; 38.5%). Almost all patients were drained (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay = 16 days). For 526 patients (83.6%), the randomized treatment was correctly administered. A total of 153 patients (23.5%) developed a grade B/C pancreatic fistula with no difference between the 2 groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (Chi-2 test, p=0.73, ITT analysis). Results remained the same after adjustment for stratification variables and in per-protocol analysis. Conclusions: Somatostatin is not more effective than octreotide in the prevention of grade B/C pancreatic fistula after pancreatectomy.