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

• Status: Active, not recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Pasireotide

Criteria

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