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

Phase 4

Active, not recruiting

• Conditions: Pancreatic Fistula; Pancreatic Neoplasms
• Interventions: Drug: Hydrocortisone; Drug: Pasireotide

• Registration Number: NCT02775227
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-14
• Study First Submitted QC: 2016-05-14
• Study First Posted: 2016-05-17
• Primary Completion: 2019-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone	Hydrocortisone	-
Pasireotide	Pasireotide	-

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index	30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
Complications (Clavien-Dindo classification)	30 days postoperatively
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland