PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA BY SOMATOSTATIN (PREFIPS)

INTERVENTION: Trade Name: Somatostatine Product Name: Somatostatine Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Acétate de somatostatine hydraté CAS Number: 51110‐01‐1 Current Sponsor code: P150915 Other descriptive name: Somatostatine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6‐ Trade Name: Siroctid Product Name: Siroctid Product Code: Octréotide Pharmaceutical Form: Solution for injection INN or Proposed INN: Acétate d’octréotide Current Sponsor code: P150915 Other descriptive name: Siroctid Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Patients candidate for pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy). ; MedDRA version: 19.0 Level: PT Classification code 10049192 Term: Pancreatic fistula System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] INCLUSION CRITERIA: o Men or women aged 18 years or greater o Signed informed consent o Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 654 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: Main Objective: To compare the grade B or C postoperative pancreatic fistula as defined by the ISGPF (International Study Group on Pancreatic Fistula) classification between patients who receive perioperative somatostatin and octreotide Primary end point(s): Percentage of patients presenting 90‐day > grade B or C postoperative pancreatic fistula as defined by the ISGPF classification between patients who receive perioperative somatostatin and octreotide.; Secondary Assessment Criteria:; 1. Percentage of 60‐day ?grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system ; 2. Percentage of 90‐day overall pancreatic fistula rate (grade A,B and C); 3. Percentage of 90‐day overall complication rate (grade 1 to 5), severe complication rate (grade 3 to 5) and mortality (Grade 5) according to Dindo‐Clavien classification ; 4. Overall duration of drainage required in patients who develop pancreatic complications (date pancreatic complication identified ‐ date drain removed); 5. Overall length of stay and 90‐days readmission rate; 6. Incremental resource utilization and cost effectiveness of perioperative somatostatin compared to octreotide to reduce the rate of postoperative fistula, assessed by 90 days evaluation of Total cost, incremental cost effectiveness ratio.; ; Secondary Objective: To compare the following endpoints between patients who receive perioperative somatostatin and octreotide:; ; 1. 60‐day >grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system; 2. 90‐day overall pancreatic fistula rate (grade A,B and C); 3. 90‐day overall complication rate (grade 1 to 5), severe complication rate (grade 3 to 5) and mortality (grade 5); 4. Overall duration of drainage required in patients who develop pancreatic complications (date pancreatic complication identified ‐ date drain removed); 5. Overall length of stay and readmission rate; 6. Cost effectiveness;