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

NCT02970175 | Completed Phase 3 DMC

• 1 other identifier: 2014/0212/HP
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Terlipressin

Outcome Measures

Primary Outcomes (1)

• Number of biopsy realized during the endoscopy

  The number of biopsy by endoscopy realized into each group will be calculated

  Day 1

Secondary Outcomes (2)

• Number of biopsy allowing an histological diagnosis

  Day 1

• Number of adverse events due to terlipressin administration

  Day 1

Study Arms (2)

Bronchoscopy with terlipressin administration

EXPERIMENTAL

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

Drug: Terlipressin administration; Procedure: bronchoscopy under local anesthesia; Procedure: Biopsy sampling

Bronchoscopy without terlipressin administration

PLACEBO COMPARATOR

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; Procedure: Biopsy sampling

Interventions

Terlipressin administration DRUG

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

Bronchoscopy with terlipressin administration

Biopsy sampling PROCEDURE

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

Bronchoscopy with terlipressin administration; Bronchoscopy without terlipressin administration

bronchoscopy under local anesthesia PROCEDURE

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

Bronchoscopy with terlipressin administration; Bronchoscopy without terlipressin administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Interventions

Chorionic Villi Sampling

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mathieu SALAUN, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 21, 2016
• Study Start: June 30, 2017
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)