HYPAR Trial - Hydrocortisone Vs. Pasireotide In Reducing Pancreatic Surgery Complications

Study Overview

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

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.

N/A

Pancreatic Fistula
Pancreatic Neoplasms

DRUG: Hydrocortisone
DRUG: Pasireotide

HYKS-190116

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-08-21
First Submitted that Met QC Criteria 2016-05-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-08-24
First Posted (ACTUAL) 2016-05-17	Results First Posted N/A	Last Verified 2020-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Hydrocortisone	DRUG: Hydrocortisone
ACTIVE_COMPARATOR: Pasireotide	DRUG: Pasireotide

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Hydrocortisone

DRUG: Hydrocortisone

ACTIVE_COMPARATOR: Pasireotide

DRUG: Pasireotide

Primary Outcome Measures	Measure Description	Time Frame
Comprehensive Complication Index		30 days postoperatively

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Tarvainen T, Siren J, Kokkola A, Sallinen V. Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):291-298. doi: 10.1001/jamasurg.2019.6019.

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Resources

Patients

Caregivers

Clinical Trial Record