HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing... | NCT02775227

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

NCT02775227

Sponsor

Helsinki University Central Hospital

Status

Active, not recruiting

Last Update Posted

Aug 24, 2020Actual

Enrollment

126Actual

Phase

Phase 4

Conditions

Pancreatic Fistula
Pancreatic Neoplasms

Interventions

Hydrocortisone
Pasireotide

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jan 2019Actual

Completion Date

Dec 2029Estimated

First Submitted Date

May 14, 2016

First Submission Date that Met QC Criteria

May 14, 2016

First Posted Date

May 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2020

Last Update Posted Date

Aug 24, 2020Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrocortisone	Experimental		Drug: Hydrocortisone
Pasireotide	Active Comparator		Drug: Pasireotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone	Drug		Hydrocortisone
Pasireotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comprehensive Complication Index		30 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Complications (Clavien-Dindo classification)		30 days postoperatively
Postoperative pancreatic fistula (ISGPS-classification)		30 days postoperatively
Postoperative delayed gastric emptying (ISGPS-classification)

Other Outcomes

Measure	Description	Time Frame
Number of patients receiving adjuvant therapy		6 months postoperatively
Overall survival		10 years
Disease free survival

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki			Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32022887	Derived	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.

ID	Term
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D005402	Fistula

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473