Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy

What Was Tested

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

The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on the location and the histological type of the lesion, as well as on the number of biopsy samples performed.

It had two arms (groups): Bronchoscopy with terlipressin administration (experimental) and Bronchoscopy without terlipressin administration (placebo comparator).

Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration.

Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done without terlipressin administration.

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 130 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients ≥18 years old. Patients scheduled to undergo bronchoscopy, presenting a suspicious radiographic lesion and a lesion proximal tumor pace viewable in white light endoscopy and without pathologic diagnosis. Patient having read and understood the information letter and signed the consent form.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: patients with contraindication to the use of terlipressin:; septic shock ,; hypersensitivity to terlipressin or the excipients or by whom use the product is not recommended:.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Terlipressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-06-30 with completion listed for 2024-04-25.

It ran at 1 site in France.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of biopsy realized during the endoscopy (time frame: Day 1).

It also tracked 2 secondary outcomes, for example Number of biopsy allowing an histological diagnosis and Number of adverse events due to terlipressin administration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 130 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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