Back to resultsHYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications (HYPAR)
Primary Purpose
Pancreatic Fistula, Pancreatic Neoplasms
Status
Active
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Hydrocortisone
Pasireotide
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Fistula
Eligibility Criteria
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
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrocortisone
Pasireotide
Arm Description
Outcomes
Primary Outcome Measures
Comprehensive Complication Index
Secondary Outcome Measures
Complications (Clavien-Dindo classification)
Postoperative pancreatic fistula (ISGPS-classification)
Postoperative delayed gastric emptying (ISGPS-classification)
Post-pancreatectomy hemorrhage (ISGPS-classification)
Length of hospital stay, days
Readmissions
Full Information
NCT ID
NCT02775227
First Posted
May 14, 2016
Last Updated
August 21, 2020
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02775227
Brief Title
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
Acronym
HYPAR
Official Title
HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula, Pancreatic Neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Title
Pasireotide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Primary Outcome Measure Information:
Title
Comprehensive Complication Index
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
Complications (Clavien-Dindo classification)
Time Frame
30 days postoperatively
Title
Postoperative pancreatic fistula (ISGPS-classification)
Time Frame
30 days postoperatively
Title
Postoperative delayed gastric emptying (ISGPS-classification)
Time Frame
30 days postoperatively
Title
Post-pancreatectomy hemorrhage (ISGPS-classification)
Time Frame
30 days postoperatively
Title
Length of hospital stay, days
Time Frame
During hospital stay, on average 7-14 days
Title
Readmissions
Time Frame
30 days postoperatively
Other Pre-specified Outcome Measures:
Title
Number of patients receiving adjuvant therapy
Time Frame
6 months postoperatively
Title
Overall survival
Time Frame
10 years
Title
Disease free survival
Time Frame
10 years
Title
Disease specific survival
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32022887
Citation
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.
Results Reference
derived
Learn more about this trial
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
We'll reach out to this number within 24 hrs