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HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
Plain-language guide to NCT02775227: phase 4 randomized trial of Pasireotide, 126 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02775227
- Phase
- phase 4
- Status
- active, not recruiting
- Start
- 2016-05
- Completion (planned or actual)
- 2019-01
- Participants
- 126 (actual)
- Design
- randomized, prevention
- Conditions studied
- Pancreatic Fistula; Pancreatic Neoplasms
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Pasireotide.
Pancreatic resections carry a high risk for complications, especially pancreatic fistula.
It had two arms (groups): Hydrocortisone (experimental) and Pasireotide (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 126 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection).
The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was randomized and parallel-group.
Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Pasireotide group and the comparison group ran side by side rather than switching.
It started in 2016-05 with completion listed for 2019-01.
It ran at 1 site in Finland.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Comprehensive Complication Index (time frame: 30 days postoperatively).
It also tracked 6 secondary outcomes, for example Complications (Clavien-Dindo classification), Postoperative pancreatic fistula (ISGPS-classification), Postoperative delayed gastric emptying (ISGPS-classification), Post-pancreatectomy hemorrhage (ISGPS-classification) and Readmissions.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Pasireotide in 126 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.