Lung Diseases, InterstitialNCT02464592
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
A study testing Transbronchial lung biopsy. in people with Lung Diseases, Interstitial, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Transbronchial lung biopsy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Aug 2017
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
- Inform consent signed.
Who cannot join
- FEV1 <40% of reference value.
- Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg).
- Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5).
- Bullous emphysema.
- Pulmonary arterial hypertension.
- Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).
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- Psychiatric illness.
- Comorbidities that could increase the risk of the TBLB.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Transbronchial lung biopsy.
- Keywords
- Cryoprobes, Transbronchial lung biopsy, Cryobiopsy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial lung biopsy.Procedure or surgery
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy with Cryoprobes | Active comparator | Transbronchial lung biopsy with a cryoprobe. Receives: Procedure: Transbronchial lung biopsy. |
| Biopsy with Conventional Forceps | Active comparator | Transbronchial lung biopsy with conventional forceps. Receives: Procedure: Transbronchial lung biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of transbronchial lung biopsy (TBLB)
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
Measured: 24 months
Secondary outcomes (3)
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
Measured: 24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
Chest radiography after TBLB.
Measured: 24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
Control of bleeding during procedure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Germans Trias i Pujol Hospital, Hospital General Universitario Santa Lucía, Hospital Universitari de Bellvitge, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Complejo Hospitalario Universitario de Vigo, University of Salamanca, Hospital Universitario de Valladolid
- Responsible party
- Sponsor
- Investigators
- Virginia Pajares, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464592
- Sponsor's protocol ID
- IIBSP-CRI-2014-05
- Status last verified
- Sep 2017
- First submitted
- 6 May 2015
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.
PubMed 24890124Pajares V, Nunez-Delgado M, Bonet G, Perez-Pallares J, Martinez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A; MULTICRIO Group researchers. Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study. PLoS One. 2020 Sep 21;15(9):e0239114. doi: 10.1371/journal.pone.0239114. eCollection 2020.
PubMed 32956379
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
- ClinicalTrials.gov ID
- NCT02464592
- Acronym / sponsor ID
- IIBSP-CRI-2014-05
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Cryoprobes, Transbronchial lung biopsy, Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Germans Trias i Pujol Hospital, Hospital General Universitario Santa Lucía, Hospital Universitari de Bellvitge, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Complejo Hospitalario Universitario de Vigo, University of Salamanca, Hospital Universitario de Valladolid
- Study start
- Apr 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 8 Jun 2015 (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 purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsy with Cryoprobes | Active comparator | Procedure: Transbronchial lung biopsy.Transbronchial lung biopsy with a cryoprobe. |
| Biopsy with Conventional Forceps | Active comparator | Procedure: Transbronchial lung biopsy.Transbronchial lung biopsy with conventional forceps. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
- Inform consent signed.
Key exclusion criteria (9 listed)
- FEV1 <40% of reference value.
- Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg).
- Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5).
- Bullous emphysema.
- Pulmonary arterial 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 |
|---|---|---|
| Transbronchial lung biopsy.Transbronchial lung biopsy with cryoprobe and with conventional forceps. | Procedure or surgery | Biopsy with Conventional Forceps, Biopsy with Cryoprobes |
Primary outcome
Diagnostic yield of transbronchial lung biopsy (TBLB)
Time frame: 24 months
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
3 secondary outcomes
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
Time frame: 24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
Time frame: 24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
Time frame: 24 months
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 29 Sep 2017.
- Background: PubMed 24890124Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.
- Derived from this study: PubMed 32956379Pajares V, Nunez-Delgado M, Bonet G, Perez-Pallares J, Martinez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A; MULTICRIO Group researchers. Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study. PLoS One. 2020 Sep 21;15(9):e0239114. doi: 10.1371/journal.pone.0239114. eCollection 2020.
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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.
Virginia Pajares, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial lung biopsy. in people with Lung Diseases, Interstitial, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 9 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 29 Sep 2017. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Diagnostic yield of transbronchial lung biopsy (TBLB) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464592, which also lists 2 linked publications.
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 29 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.