HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Helsinki University Central Hospital (HUCH)

Status and phase

Active, not recruiting

Phase 4

Conditions

Pancreatic Fistula

Pancreatic Neoplasms

Treatments

Drug: Hydrocortisone

Drug: Pasireotide

Study type

Interventional

Funder types

Other

Identifiers

NCT02775227

HYKS-190116

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)

Exclusion criteria

Preoperative exclusion criteria:
Atrophic pancreas and/or dilated pancreatic duct at the site of planned pancreatic transsection (applies only to patients undergoing pancreaticoduodenectomy)
Total pancreatectomy planned
Allergy or other contraindication for hydrocortisone or pasireotide
Age < 18 years
No informed consent
Intraoperative exclusion criteria:
Pancreatic resection cancelled (e.g. disseminated cancer)
Hard pancreas and/or dilated pancreatic duct discovered during operation (applies only to patients undergoing pancreaticoduodenectomy)
Total pancreatectomy is performed