Pancreatic Fistula, Pancreatic Neoplasms
Conditions
Brief summary
Pancreatic resections carry a high risk for complications, especially pancreatic fistula. Both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.
Interventions
DRUGHydrocortisone
DRUGPasireotide
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)
Exclusion criteria
* Preoperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive Complication Index | 30 days postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pancreatic fistula (ISGPS-classification) | 30 days postoperatively |
| Postoperative delayed gastric emptying (ISGPS-classification) | 30 days postoperatively |
| Post-pancreatectomy hemorrhage (ISGPS-classification) | 30 days postoperatively |
| Length of hospital stay, days | During hospital stay, on average 7-14 days |
| Readmissions | 30 days postoperatively |
| Complications (Clavien-Dindo classification) | 30 days postoperatively |
Other
| Measure | Time frame |
|---|---|
| Disease free survival | 10 years |
| Disease specific survival | 10 years |
| Overall survival | 10 years |
| Number of patients receiving adjuvant therapy | 6 months postoperatively |
Countries
Finland
Outcome results
None listed