Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial

What Was Tested

Researchers studied Somatostatin and Pasireotide in this randomized controlled trial publication.

ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.

Who Took Part

The study group was 281 patients.

PubMed indexes the participants as middle-aged adults, both men and women.

A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion.

Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded.

How the Study Was Run

The design is described as randomized and parallel-group.

Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Somatostatin group and the comparison group ran side by side rather than switching.

Outcome collectors and analyzers were blinded.

Modified intention-to-treat analysis was used in determination of the results.

What Was Measured

Topics PubMed links to this paper include Anti-Inflammatory Agents, Finland, Hormones, Hydrocortisone, Intention to Treat Analysis, Pancreatectomy and Pancreatic Fistula.

What This Means in Plain Language

The paper is a randomized and parallel-group study of Somatostatin and Pasireotide in 281 patients.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (JAMA surgery), a journal based in United States.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.