HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
HYPAR
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 14, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
ExpectedAugust 24, 2020
August 1, 2020
2.7 years
May 14, 2016
August 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Comprehensive Complication Index
30 days postoperatively
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Other Outcomes (4)
Number of patients receiving adjuvant therapy
6 months postoperatively
Overall survival
10 years
Disease free survival
10 years
- +1 more other outcomes
Study Arms (2)
Hydrocortisone
EXPERIMENTALPasireotide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Central Hospital
Helsinki, Finland
Related Publications (1)
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.
PMID: 32022887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 14, 2016
First Posted
May 17, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2019
Study Completion (Estimated)
December 1, 2029
Last Updated
August 24, 2020
Record last verified: 2020-08