- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775227
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
-
-
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Helsinki, Finland
- Helsinki University Central Hospital
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-
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
|
|
Active Comparator: Pasireotide
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comprehensive Complication Index
Time Frame: 30 days postoperatively
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30 days postoperatively
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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
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30 days postoperatively
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Length of hospital stay, days
Time Frame: During hospital stay, on average 7-14 days
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During hospital stay, on average 7-14 days
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Readmissions
Time Frame: 30 days postoperatively
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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
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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.
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.
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
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pathological Conditions, Anatomical
- Pancreatic Diseases
- Digestive System Fistula
- Fistula
- Pancreatic Neoplasms
- Pancreatic Fistula
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hydrocortisone
- Pasireotide
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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