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

Frontiers in Medicine

article

Elisabeth Hain¹  Emmanuel Buc²  Louise Barbier³  Jean-Christophe Vaillant⁴  Florence Jeune⁴  Laurent Sulpice⁵  Fabrice Muscari⁶  Lilian Schwarz⁷  Sophie Deguelte⁸  Antonio Sa Cunha⁹  Stephanie Truant^1,10  Alexandre Challine¹  Bertrand Dousset¹  Alain Sauvanet^1,11  Sébastien Gaujoux¹  Stylianos Tzedakis¹  Alexandru Mare¹  Alessandro Martinino¹  David Fuks^1,12  Mustapha Adham^1,13  Guillaume Piessen^1,10  Jean-Marc Regimbeau^1,14 

[1] Department of Digestive, Paris Descartes University, Cochin Hospital;Chirurgie digestive et oncologie digestive, CHU Estaing;Hôpital Trousseau;Hôpital La pitié Salpêtrière;Hôpital Universitaire Pontchaillou;Chirurgie Digestive et Transplantation Hépatique, CHU Rangueil;Hôpital Charles Nicolle;Chirurgie Viscérale, Digestive et Endocrinienne, CHU de Reims;Centre Hépatobiliaire, Hôpital Paul-Brousse;Hôpital Claude Huriez;Hôpital Beaujon;Department of Digestive, Institut Mutualiste Montsouris;HCL—Hôpital Edouard Herriot;Chirurgie digestive, CHU Amiens Picardie

关键词: pancreatic fistula;    pancreatic surgery;    somatostatin;    octreotide;    PREFIPS;   

DOI  :  10.3389/fmed.2020.00488

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY