DRUG
Somatostatin
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
Status
Completed
Phase
Phase 3
Enrollment
655
Locations
2
Results
Not posted
Publications
1
Study summary
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
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
DRUG
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
DRUG
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
Timeline
First posted
Dec 22, 2016
Study start
May 15, 2017
Primary completion
Feb 9, 2021
Study completion
Feb 9, 2021
Results posted
Not reported
Registry updated
Sep 11, 2025
Outcomes
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
Time frame · 90 days
≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
Time frame · 60 days
as defined by the MSKCC surgical secondary events system
Overall pancreatic fistula rate (grade A,B and C)
Time frame · 90 days
previous ISGPF classification
Overall pancreatic fistula rate (grade B and C)
Time frame · 90 days
last ISGPF classification
Overall complication rate (grade 1 to 5)
Time frame · 90 days
according to Clavien-Dindo classification
Severe complication rate (grade 3 to 5)
Time frame · 90 days
according to Clavien-Dindo classification
Mortality (grade 5)
Time frame · 90 days
according to Clavien-Dindo classification
Overall duration of drainage
Time frame · 90 days
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
Overall length of stay
Time frame · 90 days
Re-admission rate
Time frame · 90 days
Cost effectiveness
Time frame · 90 days
Eligibility
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
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
Cochin Hospital
Paris, Paris, France
La Pitié Salpêtrière Hospital
Paris, France
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