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

H

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

Trial design

126 participants in 2 patient groups

Hydrocortisone
Experimental group
Treatment:
Drug: Hydrocortisone
Pasireotide
Active Comparator group
Treatment:
Drug: Pasireotide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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