Pancreatic Surgery
Conditions
Keywords
Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula
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.
Interventions
DRUGSomatostatin
Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days
DRUGOctreotide
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18 years or greater * Signed informed consent * Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) | 60 days | as defined by the MSKCC surgical secondary events system |
| Overall length of stay | 90 days | — |
| Re-admission rate | 90 days | — |
| Cost effectiveness | 90 days | — |
| Fistula according to possible new definition of the ISGPF group | 90 days | — |
| Postoperative quality of life after pancreatic surgery | 7 days after surgery | only in patients undergoing pancreaticoduodenectomy |
| Overall duration of drainage | 90 days | required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed) |
Countries
France
Outcome results
None listed