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

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.

Timeline

Start

2016-05

Primary completion

2019-01

Completion

2029-12

Outcome

Missed primary endpoint

paper In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. PMID 32022887 ↗

paper The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. PMID 32022887 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrocortisone	Other / unclassified	100 mg	Intravenous
Comparator	Pasireotide	Other / unclassified	900 ug	Subcutaneous

Indications