DRUG
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
Status
Active, not recruiting
Phase
Phase 4
Enrollment
126
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Pasireotide
Timeline
From registration to results.
First posted
May 17, 2016
Study start
May 2016
Primary completion
Jan 2019
Study completion
Dec 2029
Results posted
Not reported
Registry updated
Aug 24, 2020
Outcomes
What the study measures.
Primary outcomes
Comprehensive Complication Index
Time frame · 30 days postoperatively
Secondary outcomes
Complications (Clavien-Dindo classification)
Time frame · 30 days postoperatively
Postoperative pancreatic fistula (ISGPS-classification)
Time frame · 30 days postoperatively
Postoperative delayed gastric emptying (ISGPS-classification)
Time frame · 30 days postoperatively
Post-pancreatectomy hemorrhage (ISGPS-classification)
Time frame · 30 days postoperatively
Length of hospital stay, days
Time frame · During hospital stay, on average 7-14 days
Readmissions
Time frame · 30 days postoperatively
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Finland. Showing up to 24 locations stored in the fast local snapshot.
Helsinki University Central Hospital
Helsinki, Finland
Publications
Results and literature.
Related trials
More studies on Pasireotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Novartis · Somatostatin Receptor Positive (SSTR+) · Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Phase 3
Recruiting
240
2026-04
A Study of Pasireotide in People With Prolactinoma
Memorial Sloan Kettering Cancer Center · Prolactin-Producing Pituitary Tumor
Phase 2
Recruiting
10
2026-03
Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule
RECORDATI GROUP · Pharmacokinetics · Safety
Phase 1
Completed
40
2026-02
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Advanced Accelerator Applications · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
226
2026-01
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
Hospices Civils de Lyon · Enterostomy
Phase 2
Completed
57
2025-12
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
RECORDATI GROUP · Post-Bariatric Hypoglycemia
Phase 2
Active, not recruiting
93
2025-09
Effects of Pasireotide Lar Therapy on Bone Metabolism
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Acromegaly Due to Pituitary Adenoma · Acromegaly
Not applicable
Recruiting
120
2025-09
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Castrate Resistant Prostate Cancer · Chemotherapy Naive Prostate Cancer
Phase 2
Terminated
6
2025-04
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