Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Secretin.

The pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic surgery.

It had two arms (groups): Secretin (active comparator) and Saline (placebo comparator).

Stimulate pancreatic secretion.

Placebo should not stimulate the pancreas to release its fluids.

The registry classes the interventions as drug.

More on the Plan

Their 1) secondary objectives are to determine if intra-operative intravenous secretin administration changes the management of the pancreatic resection margin intra-operatively and 2) Length of hospital stay.

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Explain the study procedures, data collection, and analysis process.

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Who Took Part

170 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Scheduled for pancreatic surgery requiring pancreatic resection at DHMC. Age greater than 18 years old. Ability to provide written informed consent.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: inability to provide written informed consent; current ongoing acute pancreatitis; pregnant or nursing mothers.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Secretin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Secretin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-05 with completion listed for 2019-09-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula (time frame: 3 days).

It also tracked 2 secondary outcomes, for example Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration and Length of Hospitalization.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Secretin in 170 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Secretin compound page, all human trials.