Interstitial Lung Diseases (ILD)NCT07910448
TBLC vs NIVATS in Interstitial Lung Disease
A study testing NIVATS biopsy and TBLC biopsy in people with Interstitial Lung Diseases (ILD), run by Rita Alexandra Afonso da Costa at 1 site in Portugal.
Trial summary
Patients with suspected interstitial lung disease (ILD) may require a lung biopsy when clinical and imaging findings are inconclusive. This single-centre pilot study randomly assigns adults (1:1) to transbronchial lung cryobiopsy (TBLC) or to non-intubated video-assisted thoracoscopic surgical biopsy (NIVATS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases (ILD)
- What is being tested?
- NIVATS biopsy and TBLC biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Nov 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Suspected ILD with non-conclusive diagnosis following multidisciplinary team discussion
- Considered suitable for both TBLC and NIVATS by the multidisciplinary team
- Able to give informed consent
Who cannot join
- ECOG Performance Status 3 or 4
- Severe Coagulopathy
- Hemodynamic instability
- Active pregnancy
- Class III obesity
- Severe obstructive sleep apnea
- Difficult airway
- Advanced comorbidity affecting life expectancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adelino Leite-Moreira, MD, PhD contact
Portugal1 site
Unidade Local de Saúde São João
Porto
Adelino Leite-Moreira, MD, PHD, +351914 015 762, joaquim.moreira@ulssjoao.min-saude.pt
rita2ac@hotmail.com
About this study
Official title: A Randomized Single-center Pilot Study Comparing Transbronchial Lung Cryobiopsy (TBLC) and Non-intubated Video-assisted Thoracoscopic Surgery (NIVATS) in Interstitial Lung Disease: Feasibility and Preliminary Estimates of Diagnostic Yield and Safety
Patients with suspected interstitial lung disease (ILD) may require a lung biopsy when clinical and imaging findings are inconclusive. This single-centre pilot study randomly assigns adults (1:1) to transbronchial lung cryobiopsy (TBLC) or to non-intubated video-assisted thoracoscopic surgical biopsy (NIVATS). Its main aims are to find out whether a larger trial is feasible (recruitment, acceptance of randomisation, completion of the assigned procedure, completeness of data) and to obtain preliminary estimates, with confidence intervals, of the diagnostic yield and the 30-day complication rate of each procedure. The study is not designed to demonstrate that one procedure is non-inferior or superior to the other; the results will be used to plan a multicentre confirmatory trial.
Read the detailed description
Despite concerns regarding morbidity and mortality, open surgical lung biopsy has traditionally been considered the gold standard. Although NIVATS and TBLC have emerged as minimally invasive alternatives, they have not yet been directly compared in a randomized clinical trial. Consequently, there is insufficient evidence to robustly compare the diagnostic yield and safety of these approaches, supporting the need for a pilot randomized trial before proceeding to a larger confirmatory study.
Participants will be randomized in a 1:1 ratio using a computer-generated randomization sequence with permuted blocks of variable size. Randomization will not be stratified. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Envelopes will be opened only after written informed consent has been obtained and the participant has been enrolled in the study. Owing to the nature of the interventions, blinding of patients, treating physicians, and pathologists will not be feasible.
The subjects of this study will be all patients with suspected ILD, who require histological diagnostic methods after clinical discussion in a multidisciplinary team (MDT) meeting. Patients who meet the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study. After enrolment, participants will be randomized to NIVATS or TBLC; the assigned procedure should ideally be performed within one month of randomization. All outcomes will be assessed 30 days follow-up visit after the procedure.
No formal interim analysis of the primary endpoint is planned, as this is a pilot study. A separate administrative review after the first 15 participants (approximately 20% of the planned enrolment) will assess recruitment, procedural feasibility and data completeness; it will test no hypothesis and carry no statistical penalty. All deaths occurring during the study will be recorded and reviewed to assess their relationship to the study procedure. A death, or any unexpected serious adverse event, considered possibly or probably related to the procedure will trigger a temporary pause in enrolment and an independent safety review by a physician not involved in the study, and the Ethics Committee will be notified. The review will determine whether any modification of the study procedures or additional safety measures are required before enrolment resumes.
This study is designed as a single-center feasibility (pilot) trial. A confirmatory non-inferiority trial would require 142 participants per arm (284 in total), assuming a diagnostic yield of 90% in both arms, a one-sided type I error of 0.025, 80% power and a non-inferiority margin of 10 percentage points on the risk-difference scale (Farrington-Manning method). This exceeds the recruitment capacity of a single center within the planned 18-month period, during which approximately 37 participants per arm (74 in total) are attainable. The study is therefore not powered to confirm non-inferiority: with the attainable sample, the two-sided 95% confidence interval for the between-arm difference in diagnostic yield is expected to be approximately +/-14 percentage points, wider than the 10-point non-inferiority margin.
Primary analysis: The primary analysis will focus on estimating the difference in diagnostic yield (TBLC - NIVATS), with corresponding two-sided 95% confidence intervals. The study is not powered to establish non-inferiority conclusively. The 10-percentage-point margin that would be used in a confirmatory trial will serve as a reference for interpreting the confidence interval, rather than as the basis for a definitive confirmatory conclusion. Effect estimates and their confidence intervals will be reported in preference to p-values.
Secondary and safety analyses: Safety and secondary endpoints will be analysed descriptively, without formal hypothesis testing. The main safety endpoint is the procedure-related complication rate, defined as the proportion of participants experiencing at least one of the following events: procedure-related 30-day mortality, acute exacerbation of ILD, severe bleeding, pneumonia, empyema, pneumothorax requiring chest drain insertion (TBLC) or postoperative air leak (NIVATS). Binary endpoints (procedure-related complication rate) will be summarized as risk differences with 95% confidence intervals; length-of-stay and length-of-drainage, which are right-skewed and subject to a competing risk of death, will be summarized as medians with interquartile ranges. All secondary analyses are exploratory.
Estimates will be presented for both the ITT and PP populations; concordance between them will inform the choice of primary analysis population for the confirmatory trial. The PP population will include participants who undergo the procedure to which they were randomised and who have no major protocol deviations affecting assessment of the primary endpoint. Participants who crossover between treatment arms will remain in their randomised group for the ITT analysis and will be excluded from the corresponding PP analysis. In the ITT analysis, participants who do not undergo the allocated procedure will be classified as non-diagnostic. Results from any subsequent biopsy or repeat procedure will not contribute to the primary diagnostic-yield endpoint, and a non-diagnostic biopsy will be classified as an unsuccessful procedure.
- Conditions
- Interstitial Lung Diseases (ILD)
- Being tested
- NIVATS biopsy, TBLC biopsy
- Keywords
- Interstitial Lung Diseases, Transbronchial Lung Cryobiopsy, Non-Intubated Video-Assisted Thoracic Surgery
- 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.
NIVATS biopsyProcedure or surgery
NIVATS is a surgical technique performed under the patient's spontaneous respiration without tracheal intubation. Patients are brought to the operating room and placed in the contralateral lateral decubitus position. The anesthesiologist initiates deep sedation combined with local infiltration at the incision site and an intercostal block guided by thoracoscopy or an erector spinae block guided by ultrasound. The lung biopsy is always performed using automatic stapling devices, sampling peripheral areas in two different lobes-usually on the right side, including the middle lobe. All patients leave the operating room with a digital chest drain, which allows for quantification of the air leak.
TBLC biopsyProcedure or surgery
TBLC is performed under general anesthesia with jet ventilation using a rigid bronchoscope (12 mm) as the main access route, through which a flexible bronchoscope is introduced. A 2.4 mm cryoprobe is used, along with real-time fluoroscopic guidance and a radial EBUS miniprobe to identify the target biopsy site. In selected cases, electromagnetic navigation can also be employed.Under fluoroscopic guidance, the cryoprobe is advanced to the selected segment until the pleural surface is reached, and then retracted 1 cm, with freezing times typically between 5 and 7 seconds. Following activation, the bronchoscope and cryoprobe are withdrawn together with the attached tissue sample.A total of 3 to 5 biopsies are generally performed per procedure, preferably from different segments within the same lobe, or different lobes from the same lung.
| Study group | Role | What they receive |
|---|---|---|
| NIVATS biopsy | Active comparator | Participants randomised to lung biopsy by non-intubated VATS under sedation and regional anaesthesia Receives: Procedure: NIVATS biopsy |
| TBLC biopsy | Experimental | Participants randomised to lung biopsy by TBLC under general anesthesia Receives: Procedure: TBLC biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological diagnostic yield
Proportion of participants in each arm achieving a high confident histopathological diagnosis
Measured: 30-day follow-up visit after the procedure
Secondary outcomes (1)
Procedure-related complications
Proportion of participants experiencing at least one complication: procedure-related 30-day mortality, acute exacerbation of ILD, severe bleeding, pneumonia, empyema, pneumothorax requiring chest drain insertion (TBLC) or postoperative air leak (NIVATS)
Measured: 30-day follow-up visit after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio using a computer-generated randomization sequence with permuted blocks of variable size. Randomization will not be stratified. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Envelopes will be opened only after written informed consent has been obtained and the participant has been formally enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rita Alexandra Afonso da Costa
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Sponsor-investigator, Rita Alexandra Afonso da Costa, Centro Hospitalar De São João, E.P.E.
- Investigators
- Adelino Leite-Moreira, MD, PhD, Study chair, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910448
- Sponsor's protocol ID
- CE-37-2026
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, the protocol and the SAP will be available from the PI on reasonable request, from 6 months to 5 years after publication, subject to a data-sharing agreement and GDPR.
Publications
Romagnoli M, Colby TV, Berthet JP, Gamez AS, Mallet JP, Serre I, Cancellieri A, Cavazza A, Solovei L, Dell'Amore A, Dolci G, Guerrieri A, Reynaud P, Bommart S, Zompatori M, Dalpiaz G, Nava S, Trisolini R, Suehs CM, Vachier I, Molinari N, Bourdin A. Poor Concordance between Sequential Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy in the Diagnosis of Diffuse Interstitial Lung Diseases. Am J Respir Crit Care Med. 2019 May 15;199(10):1249-1256. doi: 10.1164/rccm.201810-1947OC.
PubMed 30864813Fortin M, Liberman M, Delage A, Dion G, Martel S, Rolland F, Soumagne T, Trahan S, Assayag D, Albert E, Kelly MM, Johannson KA, Guenther Z, Leduc C, Manganas H, Prenovault J, Provencher S. Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE). Am J Respir Crit Care Med. 2023 Jun 15;207(12):1612-1619. doi: 10.1164/rccm.202209-1812OC.
PubMed 36796092Troy LK, Grainge C, Corte TJ, Williamson JP, Vallely MP, Cooper WA, Mahar A, Myers JL, Lai S, Mulyadi E, Torzillo PJ, Phillips MJ, Jo HE, Webster SE, Lin QT, Rhodes JE, Salamonsen M, Wrobel JP, Harris B, Don G, Wu PJC, Ng BJ, Oldmeadow C, Raghu G, Lau EMT; Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease alliance (COLDICE) Investigators. Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study. Lancet Respir Med. 2020 Feb;8(2):171-181. doi: 10.1016/S2213-2600(19)30342-X. Epub 2019 Sep 29.
PubMed 31578168Sheth JS, Belperio JA, Fishbein MC, Kazerooni EA, Lagstein A, Murray S, Myers JL, Simon RH, Sisson TH, Sundaram B, White ES, Xia M, Zisman D, Flaherty KR. Utility of Transbronchial vs Surgical Lung Biopsy in the Diagnosis of Suspected Fibrotic Interstitial Lung Disease. Chest. 2017 Feb;151(2):389-399. doi: 10.1016/j.chest.2016.09.028. Epub 2016 Oct 8.
PubMed 27729263Pompeo E, Rogliani P, Atinkaya C, Guerrera F, Ruffini E, Iniguez-Garcia MA, Peer M, Voltolini L, Caviezel C, Weder W, Opitz I, Cavalli F, Sorge R; ESTS awake thoracic surgery working group. Nonintubated surgical biopsy of undetermined interstitial lung disease: a multicentre outcome analysis. Interact Cardiovasc Thorac Surg. 2019 May 1;28(5):744-750. doi: 10.1093/icvts/ivy320.
PubMed 30508104Rossi G, Spagnolo P, Wuyts WA, Ryerson CJ, Valli M, Valentini I, Grani G, Gennari A, Bizzarro T, Lazzari-Agli L. Pathologic comparison of conventional video-assisted thoracic surgical (VATS) biopsy versus non-intubated/"awake" biopsy in fibrosing interstitial lung diseases. Respir Med. 2022 Apr-May;195:106777. doi: 10.1016/j.rmed.2022.106777. Epub 2022 Feb 22.
PubMed 35227545Zhang K, Chen HG, Wu WB, Li XJ, Wu YH, Xu JN, Jia YB, Zhang J. Non-intubated video-assisted thoracoscopic surgery vs. intubated video-assisted thoracoscopic surgery for thoracic disease: a systematic review and meta-analysis of 1,684 cases. J Thorac Dis. 2019 Aug;11(8):3556-3568. doi: 10.21037/jtd.2019.07.48.
PubMed 31559062Hutchinson JP, Fogarty AW, McKeever TM, Hubbard RB. In-Hospital Mortality after Surgical Lung Biopsy for Interstitial Lung Disease in the United States. 2000 to 2011. Am J Respir Crit Care Med. 2016 May 15;193(10):1161-7. doi: 10.1164/rccm.201508-1632OC.
PubMed 26646481Kalverda KA, Ninaber MK, Wijmans L, von der Thusen J, Jonkers RE, Daniels JM, Miedema JR, Dickhoff C, Holters J, Heineman D, Kant M, Radonic T, Shahin G, Cohen D, Boerrigter B, Nijman S, Nossent E, Braun J, Mathot B, Poletti V, Hetzel J, Dijkgraaf M, Korevaar DA, Bonta PI, Annema JT. Transbronchial cryobiopsy followed by as-needed surgical lung biopsy versus immediate surgical lung biopsy for diagnosing interstitial lung disease (the COLD study): a randomised controlled trial. Lancet Respir Med. 2024 Jul;12(7):513-522. doi: 10.1016/S2213-2600(24)00074-2. Epub 2024 Apr 16.
PubMed 38640934
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-center Pilot Study Comparing Transbronchial Lung Cryobiopsy (TBLC) and Non-intubated Video-assisted Thoracoscopic Surgery (NIVATS) in Interstitial Lung Disease: Feasibility and Preliminary Estimates of Diagnostic Yield and Safety
- ClinicalTrials.gov ID
- NCT07910448
- Acronym / sponsor ID
- CE-37-2026
- Conditions
- Interstitial Lung Diseases (ILD)
- Keywords
- Interstitial Lung Diseases, Transbronchial Lung Cryobiopsy, Non-Intubated Video-Assisted Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Rita Alexandra Afonso da CostaUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
Patients with suspected interstitial lung disease (ILD) may require a lung biopsy when clinical and imaging findings are inconclusive. This single-centre pilot study randomly assigns adults (1:1) to transbronchial lung cryobiopsy (TBLC) or to non-intubated video-assisted thoracoscopic surgical biopsy (NIVATS). Its main aims are to find out whether a larger trial is feasible (recruitment, acceptance of randomisation, completion of the assigned procedure, completeness of data) and to obtain preliminary estimates, with confidence intervals, of the diagnostic yield and the 30-day complication rate of each procedure. The study is not designed to demonstrate that one procedure is non-inferior or superior to the other; the results will be used to plan a multicentre confirmatory trial.
Detailed description
Despite concerns regarding morbidity and mortality, open surgical lung biopsy has traditionally been considered the gold standard. Although NIVATS and TBLC have emerged as minimally invasive alternatives, they have not yet been directly compared in a randomized clinical trial. Consequently, there is insufficient evidence to robustly compare the diagnostic yield and safety of these approaches, supporting the need for a pilot randomized trial before proceeding to a larger confirmatory study.
Participants will be randomized in a 1:1 ratio using a computer-generated randomization sequence with permuted blocks of variable size. Randomization will not be stratified. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Envelopes will be opened only after written informed consent has been obtained and the participant has been enrolled in the study. Owing to the nature of the interventions, blinding of patients, treating physicians, and pathologists will not be feasible.
The subjects of this study will be all patients with suspected ILD, who require histological diagnostic methods after clinical discussion in a multidisciplinary team (MDT) meeting. Patients who meet the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study. After enrolment, participants will be randomized to NIVATS or TBLC; the assigned procedure should ideally be performed within one month of randomization. All outcomes will be assessed 30 days follow-up visit after the procedure.
No formal interim analysis of the primary endpoint is planned, as this is a pilot study. A separate administrative review after the first 15 participants (approximately 20% of the planned enrolment) will assess recruitment, procedural feasibility and data completeness; it will test no hypothesis and carry no statistical penalty. All deaths occurring during the study will be recorded and reviewed to assess their relationship to the study procedure. A death, or any unexpected serious adverse event, considered possibly or probably related to the procedure will trigger a temporary pause in enrolment and an independent safety review by a physician not involved in the study, and the Ethics Committee will be notified. The review will determine whether any modification of the study procedures or additional safety measures are required before enrolment resumes.
This study is designed as a single-center feasibility (pilot) trial. A confirmatory non-inferiority trial would require 142 participants per arm (284 in total), assuming a diagnostic yield of 90% in both arms, a one-sided type I error of 0.025, 80% power and a non-inferiority margin of 10 percentage points on the risk-difference scale (Farrington-Manning method). This exceeds the recruitment capacity of a single center within the planned 18-month period, during which approximately 37 participants per arm (74 in total) are attainable. The study is therefore not powered to confirm non-inferiority: with the attainable sample, the two-sided 95% confidence interval for the between-arm difference in diagnostic yield is expected to be approximately +/-14 percentage points, wider than the 10-point non-inferiority margin.
Primary analysis: The primary analysis will focus on estimating the difference in diagnostic yield (TBLC - NIVATS), with corresponding two-sided 95% confidence intervals. The study is not powered to establish non-inferiority conclusively. The 10-percentage-point margin that would be used in a confirmatory trial will serve as a reference for interpreting the confidence interval, rather than as the basis for a definitive confirmatory conclusion. Effect estimates and their confidence intervals will be reported in preference to p-values.
Secondary and safety analyses: Safety and secondary endpoints will be analysed descriptively, without formal hypothesis testing. The main safety endpoint is the procedure-related complication rate, defined as the proportion of participants experiencing at least one of the following events: procedure-related 30-day mortality, acute exacerbation of ILD, severe bleeding, pneumonia, empyema, pneumothorax requiring chest drain insertion (TBLC) or postoperative air leak (NIVATS). Binary endpoints (procedure-related complication rate) will be summarized as risk differences with 95% confidence intervals; length-of-stay and length-of-drainage, which are right-skewed and subject to a competing risk of death, will be summarized as medians with interquartile ranges. All secondary analyses are exploratory.
Estimates will be presented for both the ITT and PP populations; concordance between them will inform the choice of primary analysis population for the confirmatory trial. The PP population will include participants who undergo the procedure to which they were randomised and who have no major protocol deviations affecting assessment of the primary endpoint. Participants who crossover between treatment arms will remain in their randomised group for the ITT analysis and will be excluded from the corresponding PP analysis. In the ITT analysis, participants who do not undergo the allocated procedure will be classified as non-diagnostic. Results from any subsequent biopsy or repeat procedure will not contribute to the primary diagnostic-yield endpoint, and a non-diagnostic biopsy will be classified as an unsuccessful procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio using a computer-generated randomization sequence with permuted blocks of variable size. Randomization will not be stratified. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Envelopes will be opened only after written informed consent has been obtained and the participant has been formally enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| NIVATS biopsy | Active comparator | Procedure: NIVATS biopsyParticipants randomised to lung biopsy by non-intubated VATS under sedation and regional anaesthesia |
| TBLC biopsy | Experimental | Procedure: TBLC biopsyParticipants randomised to lung biopsy by TBLC under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected ILD with non-conclusive diagnosis following multidisciplinary team discussion
- Considered suitable for both TBLC and NIVATS by the multidisciplinary team
- Able to give informed consent
Key exclusion criteria (8 listed)
- ECOG Performance Status 3 or 4
- Severe Coagulopathy
- Hemodynamic instability
- Active pregnancy
- Class III obesity
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 |
|---|---|---|
| NIVATS biopsyNIVATS is a surgical technique performed under the patient's spontaneous respiration without tracheal intubation. Patients are brought to the operating room and placed in the contralateral lateral decubitus position. The anesthesiologist initiates deep sedation combined with local infiltration at the incision site and an intercostal block guided by thoracoscopy or an erector spinae block guided by ultrasound. The lung biopsy is always performed using automatic stapling devices, sampling peripheral areas in two different lobes-usually on the right side, including the middle lobe. All patients leave the operating room with a digital chest drain, which allows for quantification of the air leak. | Procedure or surgery | NIVATS biopsy |
| TBLC biopsyTBLC is performed under general anesthesia with jet ventilation using a rigid bronchoscope (12 mm) as the main access route, through which a flexible bronchoscope is introduced. A 2.4 mm cryoprobe is used, along with real-time fluoroscopic guidance and a radial EBUS miniprobe to identify the target biopsy site. In selected cases, electromagnetic navigation can also be employed.Under fluoroscopic guidance, the cryoprobe is advanced to the selected segment until the pleural surface is reached, and then retracted 1 cm, with freezing times typically between 5 and 7 seconds. Following activation, the bronchoscope and cryoprobe are withdrawn together with the attached tissue sample.A total of 3 to 5 biopsies are generally performed per procedure, preferably from different segments within the same lobe, or different lobes from the same lung. | Procedure or surgery | TBLC biopsy |
Primary outcome
Histopathological diagnostic yield
Time frame: 30-day follow-up visit after the procedure
Proportion of participants in each arm achieving a high confident histopathological diagnosis
1 secondary outcome
Procedure-related complications
Time frame: 30-day follow-up visit after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 30864813Romagnoli M, Colby TV, Berthet JP, Gamez AS, Mallet JP, Serre I, Cancellieri A, Cavazza A, Solovei L, Dell'Amore A, Dolci G, Guerrieri A, Reynaud P, Bommart S, Zompatori M, Dalpiaz G, Nava S, Trisolini R, Suehs CM, Vachier I, Molinari N, Bourdin A. Poor Concordance between Sequential Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy in the Diagnosis of Diffuse Interstitial Lung Diseases. Am J Respir Crit Care Med. 2019 May 15;199(10):1249-1256. doi: 10.1164/rccm.201810-1947OC.
- Background: PubMed 36796092Fortin M, Liberman M, Delage A, Dion G, Martel S, Rolland F, Soumagne T, Trahan S, Assayag D, Albert E, Kelly MM, Johannson KA, Guenther Z, Leduc C, Manganas H, Prenovault J, Provencher S. Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE). Am J Respir Crit Care Med. 2023 Jun 15;207(12):1612-1619. doi: 10.1164/rccm.202209-1812OC.
- Background: PubMed 31578168Troy LK, Grainge C, Corte TJ, Williamson JP, Vallely MP, Cooper WA, Mahar A, Myers JL, Lai S, Mulyadi E, Torzillo PJ, Phillips MJ, Jo HE, Webster SE, Lin QT, Rhodes JE, Salamonsen M, Wrobel JP, Harris B, Don G, Wu PJC, Ng BJ, Oldmeadow C, Raghu G, Lau EMT; Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease alliance (COLDICE) Investigators. Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study. Lancet Respir Med. 2020 Feb;8(2):171-181. doi: 10.1016/S2213-2600(19)30342-X. Epub 2019 Sep 29.
- Background: PubMed 27729263Sheth JS, Belperio JA, Fishbein MC, Kazerooni EA, Lagstein A, Murray S, Myers JL, Simon RH, Sisson TH, Sundaram B, White ES, Xia M, Zisman D, Flaherty KR. Utility of Transbronchial vs Surgical Lung Biopsy in the Diagnosis of Suspected Fibrotic Interstitial Lung Disease. Chest. 2017 Feb;151(2):389-399. doi: 10.1016/j.chest.2016.09.028. Epub 2016 Oct 8.
- Background: PubMed 30508104Pompeo E, Rogliani P, Atinkaya C, Guerrera F, Ruffini E, Iniguez-Garcia MA, Peer M, Voltolini L, Caviezel C, Weder W, Opitz I, Cavalli F, Sorge R; ESTS awake thoracic surgery working group. Nonintubated surgical biopsy of undetermined interstitial lung disease: a multicentre outcome analysis. Interact Cardiovasc Thorac Surg. 2019 May 1;28(5):744-750. doi: 10.1093/icvts/ivy320.
- Background: PubMed 35227545Rossi G, Spagnolo P, Wuyts WA, Ryerson CJ, Valli M, Valentini I, Grani G, Gennari A, Bizzarro T, Lazzari-Agli L. Pathologic comparison of conventional video-assisted thoracic surgical (VATS) biopsy versus non-intubated/"awake" biopsy in fibrosing interstitial lung diseases. Respir Med. 2022 Apr-May;195:106777. doi: 10.1016/j.rmed.2022.106777. Epub 2022 Feb 22.
- Background: PubMed 31559062Zhang K, Chen HG, Wu WB, Li XJ, Wu YH, Xu JN, Jia YB, Zhang J. Non-intubated video-assisted thoracoscopic surgery vs. intubated video-assisted thoracoscopic surgery for thoracic disease: a systematic review and meta-analysis of 1,684 cases. J Thorac Dis. 2019 Aug;11(8):3556-3568. doi: 10.21037/jtd.2019.07.48.
- Background: PubMed 26646481Hutchinson JP, Fogarty AW, McKeever TM, Hubbard RB. In-Hospital Mortality after Surgical Lung Biopsy for Interstitial Lung Disease in the United States. 2000 to 2011. Am J Respir Crit Care Med. 2016 May 15;193(10):1161-7. doi: 10.1164/rccm.201508-1632OC.
- Background: PubMed 38640934Kalverda KA, Ninaber MK, Wijmans L, von der Thusen J, Jonkers RE, Daniels JM, Miedema JR, Dickhoff C, Holters J, Heineman D, Kant M, Radonic T, Shahin G, Cohen D, Boerrigter B, Nijman S, Nossent E, Braun J, Mathot B, Poletti V, Hetzel J, Dijkgraaf M, Korevaar DA, Bonta PI, Annema JT. Transbronchial cryobiopsy followed by as-needed surgical lung biopsy versus immediate surgical lung biopsy for diagnosing interstitial lung disease (the COLD study): a randomised controlled trial. Lancet Respir Med. 2024 Jul;12(7):513-522. doi: 10.1016/S2213-2600(24)00074-2. Epub 2024 Apr 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, the protocol and the SAP will be available from the PI on reasonable request, from 6 months to 5 years after publication, subject to a data-sharing agreement and GDPR.
Related trials for Interstitial Lung Diseases (ILD)
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
Not yet recruitingPhase 3
Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan
Breast Cancer, Interstitial Lung Disease (ILD)
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.
Adelino Leite-Moreira, MD, PhD contact
Adelino Leite-Moreira, MD, PhD study chair
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIVATS biopsy and TBLC biopsy in people with Interstitial Lung Diseases (ILD), run by Rita Alexandra Afonso da Costa at 1 site in Portugal.
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 8 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: opening soon, as of the sponsor's last update on 2 Nov 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Costa, Doctor of Medicine (+351919839194, rita2ac@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological diagnostic yield (time frame: 30-day follow-up visit after the procedure). 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 NCT07910448, which also lists 9 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 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.