Study Protocol of the PreFiPS Study: Prevention of Postoperative Pancreatic Fistula by Somatostatin Compared With Octreotide, a Prospective Randomized Controlled Trial - Sorbonne Université Access content directly
Journal Articles Frontiers in Medicine Year : 2021

Study Protocol of the PreFiPS Study: Prevention of Postoperative Pancreatic Fistula by Somatostatin Compared With Octreotide, a Prospective Randomized Controlled Trial

Alexandre Challine
Jean-Marc Régimbeau
Emmanuel Buc
  • Function : Author
  • PersonId : 764757
  • IdRef : 181391023
Fabrice Muscari

Abstract

Background: Pancreatic fistula (PF), i. e., a failure of the pancreatic anastomosis or closure of the remnant pancreas after distal pancreatectomy, is one of the most feared complications after pancreatic surgery. PF is also one of the most common complications after pancreatic surgery, occurring in about 30% of patients. Prevention of a PF is still a major challenge for surgeons, and various technical and pharmacological interventions have been investigated, with conflicting results. Pancreatic exocrine secretion has been proposed as one of the mechanisms by which PF occurs. Pharmacological prevention using somatostatin or its analogs to inhibit pancreatic exocrine secretion has shown promising results. We can hypothesize that continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10–50 times stronger affinity with all somatostatin receptor compared with somatostatin analogs, will be associated with an improved PF prevention. Methods: A French comparative randomized open multicentric study comparing somatostatin vs. octreotide in adult patients undergoing pancreaticoduodenectomy (PD) or distal pancreatectomy with or without splenectomy. Patients with neoadjuvant radiation therapy and/or neoadjuvant chemotherapy within 4 weeks before surgery are excluded from the study. The main objective of this study is to compare 90-day grade B or C postoperative PF as defined by the last ISGPF (International Study Group on Pancreatic Fistula) classification between patients who receive perioperative somatostatin and octreotide. In addition, we analyze overall length of stay, readmission rate, cost-effectiveness, and postoperative quality of life after pancreatic surgery in patients undergoing PD. Conclusion: The PreFiPS study aims to evaluate somatostatin vs. octreotide for the prevention of postoperative PF.
Fichier principal
Vignette du fichier
fmed-07-00488.pdf (566.84 Ko) Télécharger le fichier
Origin Publication funded by an institution

Dates and versions

hal-03128952 , version 1 (02-02-2021)

Identifiers

Cite

Elisabeth Hain, Alexandre Challine, Stylianos Tzedakis, Alexandru Mare, Alessandro Martinino, et al.. Study Protocol of the PreFiPS Study: Prevention of Postoperative Pancreatic Fistula by Somatostatin Compared With Octreotide, a Prospective Randomized Controlled Trial. Frontiers in Medicine, 2021, 7, ⟨10.3389/fmed.2020.00488⟩. ⟨hal-03128952⟩
91 View
64 Download

Altmetric

Share

Gmail Mastodon Facebook X LinkedIn More