drugset / Trial / NCT02970175

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

NCT02970175

Phase 3 Completed 130 enrolled University Hospital, Rouen
RandomizedParallel-groupDouble-blindPrevention

Summary

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. The increasing number of sampling is also important to provide material for molecular assessment of lung cancer. The French National Institute for Cancer recommends a number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing the number of bronchial biopsies comes with a higher risk of bleeding, the management of endobronchial bleeding may be determinant for the diagnostic yield. The most recent recommendations of the British Thoracic Society for the management of bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of 1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include the use of endobronchial terlipressin, which has local vasoconstriction effect. After endobronchial administration of terlipressin, plasmatic concentrations are low, and are not clinically relevant. The hypothesis of this clinical trial is that endobronchial instillation of terlipressin before sampling endobronchial tumor will limit the endobronchial bleeding and allow to increase the number of biopsies performed and, eventually, the diagnostic yield.

Timeline

Start
2017-06-30
Primary completion
2024-04-25
Completion
2024-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide

Indications

No indication recorded.