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

Phase 4Active Not RecruitingNCT02775227

Helsinki University Central Hospital126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Enrollment

126

Conditions

Pancreatic Fistula Pancreatic Neoplasms

Interventions

HydrocortisoneDRUG

PasireotideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland