Prevention of Postoperative Pancreatic Fistula by Somatostatin
- Registration Number
- NCT03000946
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
- Detailed Description
Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results.
Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection.
In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention.
Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 655
- Men or women aged 18 years or greater
- Signed informed consent
- Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
- Patient with radiation therapy
- Patient with neoadjuvant chemotherapy within 4 weeks before surgery
- Pregnancy
- Breastfeeding
- Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
- Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
- Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations
- Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
- Patients treated by ciclosporin
- Patient without health insurance or social security
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somatostatin Somatostatin Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days Octreotide Octreotide Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.
- Primary Outcome Measures
Name Time Method ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification 90 days
- Secondary Outcome Measures
Name Time Method Overall pancreatic fistula rate (grade A,B and C) 90 days previous ISGPF classification
Overall pancreatic fistula rate (grade B and C) 90 days last ISGPF classification
Overall complication rate (grade 1 to 5) 90 days according to Clavien-Dindo classification
Severe complication rate (grade 3 to 5) 90 days according to Clavien-Dindo classification
Mortality (grade 5) 90 days according to Clavien-Dindo classification
Overall duration of drainage 90 days required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
Cost effectiveness 90 days Overall length of stay 90 days Fistula according to possible new definition of the ISGPF group 90 days ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) 60 days as defined by the MSKCC surgical secondary events system
Re-admission rate 90 days Postoperative quality of life after pancreatic surgery 7 days after surgery only in patients undergoing pancreaticoduodenectomy
Trial Locations
- Locations (2)
Cochin Hospital
🇫🇷Paris, France
La Pitié Salpêtrière Hospital
🇫🇷Paris, France