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Trial · Interventional

Active, not recruitingPhase 4Registry data

HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Short name HYPAR

NCTNCT02775227 (opens ClinicalTrials.gov in a new tab)Other idHYKS-190116
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
126 participants (actual)
Sponsor
Helsinki University Central Hospital · Other
Design
Randomized
Countries
1 country

Finland

Start
May 2016
Primary completion
Jan 2019
Completion
Dec 2029 (estimated)
First posted
17 May 2016 (estimated)
Last update posted
24 Aug 2020
Conditions
Pancreatic Fistula · Pancreatic Neoplasms

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020252030
  1. Ph 4

    HYPAR

    NCT02775227

    May 2016 to est. Dec 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • HydrocortisoneDrug
  • PasireotideDrug

Arms2

  • Experimental

    Hydrocortisone

  • Active comparator

    Pasireotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Comprehensive Complication Index

    Time frame · 30 days postoperatively

Secondary outcomes(6)

  1. Complications (Clavien-Dindo classification)

    Time frame · 30 days postoperatively

  2. Postoperative pancreatic fistula (ISGPS-classification)

    Time frame · 30 days postoperatively

  3. Postoperative delayed gastric emptying (ISGPS-classification)

    Time frame · 30 days postoperatively

  4. Post-pancreatectomy hemorrhage (ISGPS-classification)

    Time frame · 30 days postoperatively

  5. Length of hospital stay, days

    Time frame · During hospital stay, on average 7-14 days

  6. Readmissions

    Time frame · 30 days postoperatively

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

5 results

Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.

Tarvainen et al. 2020JAMA surgerycited by 49

PMID 32022887PMC7042940DOI 10.1001/jamasurg.2019.6019PUB-32022887

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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