Bronchial EndoscopyPhase 3TERLABNCT02970175
Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy
A Phase 3 study testing Terlipressin administration, bronchoscopy under local anesthesia and Biopsy sampling in people with Bronchial Endoscopy, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Endoscopy
- What is being tested?
- Terlipressin administration, bronchoscopy under local anesthesia and Biopsy sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2017to 25 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Terlipressin administration, bronchoscopy under local anesthesia, Biopsy sampling
- Keywords
- Terlipressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin administrationDrug
Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
bronchoscopy under local anesthesiaProcedure or surgery
Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
Biopsy samplingProcedure or surgery
Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: bronchoscopy under local anesthesia; Procedure: Biopsy sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biopsy realized during the endoscopy
The number of biopsy by endoscopy realized into each group will be calculated
Measured: Day 1
Secondary outcomes (2)
Number of biopsy allowing an histological diagnosis
The number of biopsy allowing an histological diagnosis into each group will be calculated
Measured: Day 1
Number of adverse events due to terlipressin administration
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start30 Jun 2017
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial EndoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu SALAUN, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970175
- Sponsor's protocol ID
- 2014/212/HP
- Acronym
- TERLAB
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2016
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy
- ClinicalTrials.gov ID
- NCT02970175
- Acronym / sponsor ID
- TERLAB / 2014/212/HP
- Conditions
- Bronchial Endoscopy
- Keywords
- Terlipressin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy with terlipressin administration | Experimental | Drug: Terlipressin administration, Procedure: bronchoscopy under local anesthesia, Procedure: Biopsy samplingPatients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration |
| Bronchoscopy without terlipressin administration | Placebo comparator | Procedure: bronchoscopy under local anesthesia, Procedure: Biopsy samplingPatients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done without terlipressin administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terlipressin administrationPatients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration | Drug | Bronchoscopy with terlipressin administration |
| bronchoscopy under local anesthesiaPatients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration | Procedure or surgery | Bronchoscopy with terlipressin administration, Bronchoscopy without terlipressin administration |
| Biopsy samplingPatients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration | Procedure or surgery | Bronchoscopy with terlipressin administration, Bronchoscopy without terlipressin administration |
Primary outcome
Number of biopsy realized during the endoscopy
Time frame: Day 1
The number of biopsy by endoscopy realized into each group will be calculated
2 secondary outcomes
Number of biopsy allowing an histological diagnosis
Time frame: Day 1
Number of adverse events due to terlipressin administration
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu SALAUN, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terlipressin administration, bronchoscopy under local anesthesia and Biopsy sampling in people with Bronchial Endoscopy, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biopsy realized during the endoscopy (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.