Lung Diseases, InterstitialNCT03596528
Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.
A study testing Lung biopsy in people with Lung Diseases, Interstitial, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Lung biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2018to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.
- Subject provides informed consent.
- A negative pregnancy test in women of child-bearing potential.
- Subject is mentally capable of understanding study procedures.
- 18 years and older.
Who cannot join
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
- Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
- Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
Alejandra Libreros Niño, M.D., +34628296229, LIBREROS@clinic.cat
Alejandra Libreros Niño, +34628296229, LIBREROS@clinic.cat
About this study
Official title: Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.
In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy
Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .
Read more
The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC
Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.
This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.
The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.
Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Lung biopsy
- Keywords
- Interstitial lung disease, cryobiopsy, surgical biopsy
- 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.
Lung biopsyProcedure or surgery
Also called Cryobiopsy
Each patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage.
| Study group | Role | What they receive |
|---|---|---|
| Lung biopsy | Other | Lung biopsy Receives: Procedure: Lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the tissue sample reported by the pathologist.
comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.
Measured: for statistical analysis, 12 months after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start23 Mar 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Hospital Clinic of BarcelonaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Libreros Niño, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596528
- Sponsor's protocol ID
- HCB/2017/0900
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066Xaubet A, Ancochea J, Bollo E, Fernandez-Fabrellas E, Franquet T, Molina-Molina M, Montero MA, Serrano-Mollar A; Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Guidelines for the diagnosis and treatment of idiopathic pulmonary fibrosis. Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Arch Bronconeumol. 2013 Aug;49(8):343-53. doi: 10.1016/j.arbres.2013.03.011. Epub 2013 Jun 4. English, Spanish.
PubMed 23742884Walker CM, Chung JH, Wall C, Pipavath SN, Chapman T, Reddy GP, Stern EJ, Godwin JD, Weinberger E. Interactive high-resolution computed tomography digital atlas of interstitial lung disease. Acad Radiol. 2011 Nov;18(11):1453-60. doi: 10.1016/j.acra.2011.07.008. Epub 2011 Sep 1.
PubMed 21889896Rena O, Casadio C, Leo F, Giobbe R, Cianci R, Baldi S, Rapellino M, Maggi G. Videothoracoscopic lung biopsy in the diagnosis of interstitial lung disease. Eur J Cardiothorac Surg. 1999 Dec;16(6):624-7. doi: 10.1016/s1010-7940(99)00320-6.
PubMed 10647831American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.
PubMed 10673212Lentz RJ, Argento AC, Colby TV, Rickman OB, Maldonado F. Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. J Thorac Dis. 2017 Jul;9(7):2186-2203. doi: 10.21037/jtd.2017.06.96.
PubMed 28840020Fibla JJ, Molins L, Simon C, Perez J, Vidal G. Early removal of chest drainage after videothoracoscopic lung biopsy. Interact Cardiovasc Thorac Surg. 2006 Oct;5(5):581-3. doi: 10.1510/icvts.2006.129338. Epub 2006 Jun 28.
PubMed 17670651Katzenstein AL, Myers JL. Idiopathic pulmonary fibrosis: clinical relevance of pathologic classification. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1301-15. doi: 10.1164/ajrccm.157.4.9707039. No abstract available.
PubMed 9563754Hodnett PA, Naidich DP. Fibrosing interstitial lung disease. A practical high-resolution computed tomography-based approach to diagnosis and management and a review of the literature. Am J Respir Crit Care Med. 2013 Jul 15;188(2):141-9. doi: 10.1164/rccm.201208-1544CI.
PubMed 23672718Shorr AF, Lettieri CJ, Helman DL. Role for transbronchial biopsy in the diagnosis of usual interstitial pneumonia. Chest. 2007 Jan;131(1):329-30; author reply 330. doi: 10.1378/chest.06-1266. No abstract available.
PubMed 17218598Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.
PubMed 19246874Berbescu EA, Katzenstein AL, Snow JL, Zisman DA. Transbronchial biopsy in usual interstitial pneumonia. Chest. 2006 May;129(5):1126-31. doi: 10.1378/chest.129.5.1126.
PubMed 16685001Xaubet A, Ancochea J, Blanquer R, Montero C, Morell F, Rodriguez Becerra E, Sueiro A, Villena V; Grupo de Investigacion en Enfermedades Pulmonares Intersticiales Difusas. Area de Tecnicas y Transplante. SEPAR. [Diagnosis and treatment of diffuse interstitial lung diseases]. Arch Bronconeumol. 2003 Dec;39(12):580-600. doi: 10.1016/s0300-2896(03)75457-x. No abstract available. Spanish.
PubMed 14636495
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.
- ClinicalTrials.gov ID
- NCT03596528
- Acronym / sponsor ID
- HCB/2017/0900
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Interstitial lung disease, cryobiopsy, surgical biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 24 Jul 2018 (actual)
- 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.
In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy
Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .
The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC
Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.
This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.
The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.
Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung biopsy | Other | Procedure: Lung biopsyLung biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.
- Subject provides informed consent.
- A negative pregnancy test in women of child-bearing potential.
- Subject is mentally capable of understanding study procedures.
- 18 years and older.
Key exclusion criteria (7 listed)
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
- Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
- Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements
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 |
|---|---|---|
| Lung biopsyAlso: CryobiopsyEach patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage. | Procedure or surgery | Lung biopsy |
Primary outcome
Quality of the tissue sample reported by the pathologist.
Time frame: for statistical analysis, 12 months after the first inclusion
comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Background: PubMed 23742884Xaubet A, Ancochea J, Bollo E, Fernandez-Fabrellas E, Franquet T, Molina-Molina M, Montero MA, Serrano-Mollar A; Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Guidelines for the diagnosis and treatment of idiopathic pulmonary fibrosis. Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Arch Bronconeumol. 2013 Aug;49(8):343-53. doi: 10.1016/j.arbres.2013.03.011. Epub 2013 Jun 4. English, Spanish.
- Background: PubMed 21889896Walker CM, Chung JH, Wall C, Pipavath SN, Chapman T, Reddy GP, Stern EJ, Godwin JD, Weinberger E. Interactive high-resolution computed tomography digital atlas of interstitial lung disease. Acad Radiol. 2011 Nov;18(11):1453-60. doi: 10.1016/j.acra.2011.07.008. Epub 2011 Sep 1.
- Background: PubMed 10647831Rena O, Casadio C, Leo F, Giobbe R, Cianci R, Baldi S, Rapellino M, Maggi G. Videothoracoscopic lung biopsy in the diagnosis of interstitial lung disease. Eur J Cardiothorac Surg. 1999 Dec;16(6):624-7. doi: 10.1016/s1010-7940(99)00320-6.
- Background: PubMed 10673212American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.
- Background: PubMed 28840020Lentz RJ, Argento AC, Colby TV, Rickman OB, Maldonado F. Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. J Thorac Dis. 2017 Jul;9(7):2186-2203. doi: 10.21037/jtd.2017.06.96.
- Background: PubMed 17670651Fibla JJ, Molins L, Simon C, Perez J, Vidal G. Early removal of chest drainage after videothoracoscopic lung biopsy. Interact Cardiovasc Thorac Surg. 2006 Oct;5(5):581-3. doi: 10.1510/icvts.2006.129338. Epub 2006 Jun 28.
- Background: PubMed 9563754Katzenstein AL, Myers JL. Idiopathic pulmonary fibrosis: clinical relevance of pathologic classification. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1301-15. doi: 10.1164/ajrccm.157.4.9707039. No abstract available.
- Background: PubMed 23672718Hodnett PA, Naidich DP. Fibrosing interstitial lung disease. A practical high-resolution computed tomography-based approach to diagnosis and management and a review of the literature. Am J Respir Crit Care Med. 2013 Jul 15;188(2):141-9. doi: 10.1164/rccm.201208-1544CI.
- Background: PubMed 17218598Shorr AF, Lettieri CJ, Helman DL. Role for transbronchial biopsy in the diagnosis of usual interstitial pneumonia. Chest. 2007 Jan;131(1):329-30; author reply 330. doi: 10.1378/chest.06-1266. No abstract available.
- Background: PubMed 19246874Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.
- Background: PubMed 16685001Berbescu EA, Katzenstein AL, Snow JL, Zisman DA. Transbronchial biopsy in usual interstitial pneumonia. Chest. 2006 May;129(5):1126-31. doi: 10.1378/chest.129.5.1126.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung biopsy in people with Lung Diseases, Interstitial, run by Hospital Clinic of Barcelona 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Libreros Niño, MD (+34628296229, LIBREROS@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the tissue sample reported by the pathologist. (time frame: for statistical analysis, 12 months after the first inclusion). 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 NCT03596528, which also lists 13 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 26 Jul 2018.