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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2029-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Pancreatic Fistula Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

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Hydrocortisone

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Pasireotide

Group Type ACTIVE_COMPARATOR

Pasireotide

Intervention Type DRUG

Interventions

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Hydrocortisone

Intervention Type DRUG

Pasireotide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No