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Active, not recruitingNCT02775227HYPARUpdated Aug 24, 2020

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

A Phase 4 interventional study of Hydrocortisone and Pasireotide in Pancreatic Fistula and Pancreatic Neoplasms, sponsored by Helsinki University Central Hospital. Active, not recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-24.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pancreatic Fistula
  • Pancreatic Neoplasms
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 126 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)

Exclusion criteria

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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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
126 participants (actual)

Study arms

  • Experimental
    Hydrocortisone

    Drug: Hydrocortisone

  • Active comparator
    Pasireotide

    Drug: Pasireotide

Interventions

  • DrugHydrocortisone
  • DrugPasireotide
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What researchers measure

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: 30 days postoperatively

Secondary outcomes

  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

Other outcomes

  1. Number of patients receiving adjuvant therapy

    Time frame: 6 months postoperatively

  2. Overall survival

    Time frame: 10 years

  3. Disease free survival

    Time frame: 10 years

  4. Disease specific survival

    Time frame: 10 years

07

Study locations

1 site
  • Helsinki University Central Hospital
    Helsinki, Finland
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References and documents

Publications

  • 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. PubMed 32022887 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02775227
Lead sponsor
Helsinki University Central Hospital
Responsible party
Ville Sallinen (MD, PhD, Helsinki University Central Hospital) — Principal investigator
First posted
May 17, 2016
Start date
May 2016
Primary completion
Jan 2019
Completion
Dec 2029 (estimated)
Last update
Aug 24, 2020
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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