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Published on: March 12, 2019
Study Protocol of the PreFiPS Study: Prevention of Postoperative Pancreatic Fistula by Somatostatin Compared With
Elisabeth Hain1, Alexandre Challine1, Stylianos Tzedakis1
1Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris Descartes University, Cochin Hospital, Paris, France.
Insights
This study compares somatostatin and octreotide to prevent pancreatic fistula (PF), a common complication after pancreatic surgery. The goal is to determine which drug is more effective in preventing postoperative pancreatic fistula.
Area of Science:
- Gastroenterology and Surgical Oncology
- Pharmacology and Drug Development
Background:
- Pancreatic fistula (PF) is a frequent and feared complication following pancreatic surgery, affecting approximately 30% of patients.
- Current prevention strategies for PF, including surgical techniques and pharmacological interventions, yield conflicting results.
- Inhibition of pancreatic exocrine secretion is a proposed mechanism for PF prevention, with somatostatin and its analogs showing promise.
Purpose of the Study:
- To compare the efficacy of perioperative somatostatin versus octreotide in preventing postoperative pancreatic fistula (PF) of grade B or C.
- To evaluate the impact of somatostatin and octreotide on length of stay, readmission rates, cost-effectiveness, and quality of life after pancreatic surgery.
Main Methods:
- A French multicenter randomized open study comparing continuous intravenous somatostatin-14 with octreotide in adult patients undergoing pancreaticoduodenectomy or distal pancreatectomy.
- Exclusion criteria include neoadjuvant chemoradiation within 4 weeks of surgery.
- The primary endpoint is the 90-day incidence of grade B or C PF, according to the International Study Group on Pancreatic Fistula (ISGPF) classification.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- The PreFiPS study is designed to assess whether somatostatin-14 is superior to octreotide in preventing postoperative pancreatic fistula.
- Findings will inform clinical practice regarding the optimal pharmacological agent for PF prevention in pancreatic surgery.
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.
