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
Conditions
Interventions
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
C
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: o Patient with neoadjuvant chemo and/or radiation therapy o Pregnancy o Breastfeeding o Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis o Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated thromboplastin time) o Patients with WBC <3 X 109/L; PLT <100 X 109/L o 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 o Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion o Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations o Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations o Patients treated by ciclosporine o Patient without health insurance or social security o 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 |
|---|---|
| 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;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 ;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. | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed