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Randomized Controlled Trial
. 2024 Aug 1;280(2):179-187.
doi: 10.1097/SLA.0000000000006313. Epub 2024 Apr 25.

Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study

Sébastien Gaujoux  1   2 , Jean-Marc Regimbeau  3   4 , Guillaume Piessen  5   6 , Stéphanie Truant  6   7 , Frantz Foissac  8 , Louise Barbier  9   10 , Emmanuel Buc  11   12 , Mustapha Adham  13   14 , David Fuks  15   16 , Sophie Deguelte  17   18 , Fabrice Muscari  19   20 , Laurent Sulpice  21   22 , Jean-Christophe Vaillant  1   2 , Lilian Schwarz  23   24 , Antonio Sa Cunha  25   26 , Milena Muzzolini  1   2 , Bertrand Dousset  15   16 , Alain Sauvanet  27   28 ; Collaborators
Collaborators, Affiliations
Randomized Controlled Trial

Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study

Sébastien Gaujoux et al. Ann Surg. .

Abstract

Objective: 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 versus octreotide as prophylactic treatment.

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 versus octreotid 100 μg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs DP) and size of the main pancreatic duct (>4 mm) on grade B/C POPF rates at 90 days based on an intention-to-treat analysis.

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 nondilated 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 days). 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 (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis.

Conclusion: Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy.

Findings: In the PREFIPS Randomized Clinical Trial including 651 patients, a total of 153 patients (23.5%) developed a grade B/C POPF with no significant difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis.

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Conflict of interest statement

S.G. reported grants, personal fees, and nonfinancial support fomr IPSEN, Mylan, Mayoli, Novartis. The remaining authors report no conflicts of interest.

References

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