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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
655
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
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
Cochin Hospital
Paris, Paris, France
La Pitié Salpêtrière Hospital
Paris, France
≥ 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)
as defined by the MSKCC surgical secondary events system
Time frame: 60 days
Overall pancreatic fistula rate (grade A,B and C)
previous ISGPF classification
Time frame: 90 days
Overall pancreatic fistula rate (grade B and C)
last ISGPF classification
Time frame: 90 days
Overall complication rate (grade 1 to 5)
according to Clavien-Dindo classification
Time frame: 90 days
Severe complication rate (grade 3 to 5)
according to Clavien-Dindo classification
Time frame: 90 days
Mortality (grade 5)
according to Clavien-Dindo classification
Time frame: 90 days
Overall duration of drainage
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
Time frame: 90 days
Overall length of stay
Time frame: 90 days
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Re-admission rate
Time frame: 90 days
Cost effectiveness
Time frame: 90 days
Fistula according to possible new definition of the ISGPF group
Time frame: 90 days
Postoperative quality of life after pancreatic surgery
only in patients undergoing pancreaticoduodenectomy
Time frame: 7 days after surgery