Pancreatic FistulaPhase 4HYPARNCT02775227
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
A Phase 4 study testing Hydrocortisone and Pasireotide in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula, Pancreatic Neoplasms
- What is being tested?
- Hydrocortisone and Pasireotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
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.
- Conditions
- Pancreatic Fistula, Pancreatic Neoplasms
- Being tested
- Hydrocortisone, Pasireotide
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
PasireotideDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | Not described Receives: Drug: Hydrocortisone |
| Pasireotide | Active comparator | Not described Receives: Drug: Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index
Measured: 30 days postoperatively
Secondary outcomes (6)
Complications (Clavien-Dindo classification)
Measured: 30 days postoperatively
Postoperative pancreatic fistula (ISGPS-classification)
Measured: 30 days postoperatively
Postoperative delayed gastric emptying (ISGPS-classification)
Measured: 30 days postoperatively
Post-pancreatectomy hemorrhage (ISGPS-classification)
Measured: 30 days postoperatively
Length of hospital stay, days
Measured: During hospital stay, on average 7-14 days
Readmissions
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2019
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775227
- Sponsor's protocol ID
- HYKS-190116
- Acronym
- HYPAR
- Status last verified
- Aug 2020
- First submitted
- 14 May 2016
- Last updated
- 24 Aug 2020
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02775227
- Acronym / sponsor ID
- HYPAR / HYKS-190116
- Conditions
- Pancreatic Fistula, Pancreatic Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: Hydrocortisone |
| Pasireotide | Active comparator | Drug: Pasireotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone | Drug | Hydrocortisone |
| Pasireotide | Drug | Pasireotide |
Primary outcome
Comprehensive Complication Index
Time frame: 30 days postoperatively
6 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Derived from this study: PubMed 32022887Tarvainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Pasireotide in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.