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

August 21, 2020 updated by: Ville Sallinen, Helsinki University Central Hospital

HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrocortisone
Drug: Hydrocortisone
Active Comparator: Pasireotide
Drug: Pasireotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comprehensive Complication Index
Time Frame: 30 days postoperatively
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications (Clavien-Dindo classification)
Time Frame: 30 days postoperatively
30 days postoperatively
Postoperative pancreatic fistula (ISGPS-classification)
Time Frame: 30 days postoperatively
30 days postoperatively
Postoperative delayed gastric emptying (ISGPS-classification)
Time Frame: 30 days postoperatively
30 days postoperatively
Post-pancreatectomy hemorrhage (ISGPS-classification)
Time Frame: 30 days postoperatively
30 days postoperatively
Length of hospital stay, days
Time Frame: During hospital stay, on average 7-14 days
During hospital stay, on average 7-14 days
Readmissions
Time Frame: 30 days postoperatively
30 days postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 10 years
10 years
Number of patients receiving adjuvant therapy
Time Frame: 6 months postoperatively
6 months postoperatively
Disease free survival
Time Frame: 10 years
10 years
Disease specific survival
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

Helsinki University Central Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

May 14, 2016

First Submitted That Met QC Criteria

May 14, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYKS-190116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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