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

NCT02970175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Bronchial Endoscopy

Interventions

DRUG

Terlipressin administration

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

PROCEDURE

bronchoscopy under local anesthesia

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

PROCEDURE

Biopsy sampling

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Mathieu SALAUN, MD · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970175 on ClinicalTrials.gov