Somatostatin vs. Octreotide for Prevention of Postoperative Pancreatic Fistula The PREFIPS Randomized Clinical Trial A FRENCH 007 – ACHBT Study
Sébastien Gaujoux, Jean-Marc Regimbeau, Guillaume Piessen, Stéphanie Truant, Frantz Foissac, Louise Barbier, Emmanuel Buc, Mustapha Adham, David Fuks, Sophie Deguelte, Fabrice Muscari, Laurent Sulpice, Jean-Christophe Vaillant, Lilian Schwarz, Antonio Sa Cunha, Milena Muzzolini, Bertrand Dousset, Alain SauvanetObjective:
Pharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin
Patients and methods:
Multicentric randomized controlled open study in patient’s candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days
Results:
Of 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, with comparable the stratification criteria - type of surgery and main pancreatic duct dilatation. 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 pancreatic adenocarcinoma (n=311; 47.8%). Almost all patients had abdominal drainage (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay=16 d). A total of 153 patients (23.5%) developed a grade B/C POPF with no difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (Chi-2 test,
Conclusions:
Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy.