Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy (NCT02970175) | Clinical Trial Compass
CompletedPhase 3
Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy
France130 participantsStarted 2017-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.