Patients undergoing pancreatic resection.
Conditions
Interventions
Trade Name: Signifor
Pharmaceutical Form: Injection
CAS Number: 396091-73-9
Other descriptive name: PASIREOTIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 900-
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing pancreatic resection. 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: - Atrophic pancreas, dilated main pancreatic duct at the site of pancreaticojejunostomy - Total pancreatectomy - Allergy to studied medications - Age < 18 years - No written consent - Pancreatic resection not performed, even if planned - Hard pancreas/dilated main pancreatic duct (only patients undergoing PD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine non-inferiority of hydrocortisone compared to pasireotide in preventing pancreatic surgery complications.;Secondary Objective: Determine oncological survival;Primary end point(s): Comprehensive complication index ;Timepoint(s) of evaluation of this end point: 30 days postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Complications (C-D classification) - Pancreatic fistula (ISGPS classification) - DGE (ISGPS classification) - Post-pancreatectomy hemorrhage (ISGPS classification) - Duration of hospital stay - Readmissions - Number of patients who received adjuvant therapy;Timepoint(s) of evaluation of this end point: 30 days, except for adjuvant therapy 6 months. | — |
Countries
Finland
Contacts
Public ContactMEM13
Helsinki University Central Hospital
Outcome results
None listed