Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy (TERLAB)

May 25, 2018 updated by: University Hospital, Rouen

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.

Study Overview

Status

Unknown

Conditions

Bronchial Endoscopy

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mathieu SALAUN, MD
Phone Number: 8265 +3323288
Email: mathieu.salaun@chu-rouen.fr

Study Locations

France
- - Rouen, France
    - Recruiting
    - ROUEN university hospital
    - Contact:
      
      Mathieu SALAUN, MD
    - Principal Investigator:
      
      Mathieu SALAUN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
Effective contraception in women of childbearing age

Exclusion Criteria:

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:
Recent history (<3 months) of acute coronary syndrome (including myocardial infarction) or unbalanced coronary insufficiency, or disorders of the ventricular heart rate.
severe uncontrolled hypertension,
cerebrovascular insufficiency and ischemic stroke of recent origin (<3 months).
severe arterial occlusive lower extremities,
severe chronic renal impairment (GFR <20 ml / min).
Patients receiving uninterrupted antiplatelet therapy during 5 days before endoscopy (7 days for Clopidogrel Related), including low dose aspirin (≤ 75 mg / day).
Patients receiving anticoagulant therapy:
Unfractionated heparin within 12 hours before endoscopy.
low molecular weight heparin within 24 hours before endoscopy.
Patients with bleeding disorders defined by TP below 70% or TCA ratio patient / control greater than 1.3.
Patients with thrombocytopenia less than 100 g / L.
Subjects misunderstanding of spoken and written French
Person under guardianship or deprived of liberty by judicial or administrative decision (under Article L1121-6 and L1121-8 of Public Health Code
Pregnant or lactating women, premenopausal women without adequate contraception
Patient participating in other drug testing or participating in another drug test in the previous month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronchoscopy with terlipressin administration Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration	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
Placebo Comparator: Bronchoscopy without terlipressin administration Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done without 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