Etude : TERLAB /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : TERLAB

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH1

Dernière MÀJ : 07/01/2022
CIM10 - Localisation(s)
Informations principales
Titre : Intérêt de l'administration de TERLipressine in situ, avant la réalisation de Biopsies bronchiques.

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : 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 Arms

•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

•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

Phase : III

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : •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

Critères de non-inclusion : •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
Informations relatives au promoteur
Promoteur :
CHU de Rouen
Type de sponsor : Institutionnel
76000 ROUEN

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Clément Fournier

Eric Wasielewski

Statut de l'essai : OUVERT

MAJ : 23/10/2018 (anglais) :