Lung Ground-Glass OpacityNCT04727190
The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO
A study testing Transbronchial Cryobiopsy and Transbronchial Forceps Biopsy in people with Lung Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Ground-Glass Opacity
- What is being tested?
- Transbronchial Cryobiopsy and Transbronchial Forceps Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 80.
- CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
- Thin-slice CT scan with bronchial access or adjacent lesions.
- Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
- It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
- Ability to read, understand and sign ICF.
Who cannot join
- Disseminated GGO, suspected of benign or infectious lesions.
- Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
- There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
- Intolerance or difficulty in cooperating with bronchoscopy, etc.
- Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
- Vulnerable groups, such as pregnant women, etc.
- Some other special situations investigator consider subjects are not suitable to participant in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Jiayuan Sun, MD,PhD, +86-021-22200000 ext. 1511, xkyyjysun@163.com
About this study
Official title: The Efficacy and Safety of Transbronchial Cryobiopsy vs Forceps Biopsy in the Diagnosis of Lung Ground-glass Opacity: A Prospective, Randomized Controlled Trial
The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.
Read the detailed description
The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.
- Conditions
- Lung Ground-Glass Opacity
- Being tested
- Transbronchial Cryobiopsy, Transbronchial Forceps Biopsy
- Keywords
- Lung Ground-Glass Opacity, Transbronchial Cryobiopsy, Forceps Biopsy, Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial CryobiopsyProcedure or surgery
The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.
Transbronchial Forceps BiopsyProcedure or surgery
The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.
| Study group | Role | What they receive |
|---|---|---|
| TBCB group | Experimental | Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope. Receives: Procedure: Transbronchial Cryobiopsy |
| TBFB group | Active comparator | Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope. Receives: Procedure: Transbronchial Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.
Measured: Up to 6 Months
Secondary outcomes (1)
Tissue size
The maximum diameter measured by the biopsy tissue.
Measured: Up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung Ground-Glass OpacityStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727190
- Sponsor's protocol ID
- SHCHE201904
- Status last verified
- Jan 2021
- First submitted
- 15 Mar 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heidinger BH, Anderson KR, Nemec U, Costa DB, Gangadharan SP, VanderLaan PA, Bankier AA. Lung Adenocarcinoma Manifesting as Pure Ground-Glass Nodules: Correlating CT Size, Volume, Density, and Roundness with Histopathologic Invasion and Size. J Thorac Oncol. 2017 Aug;12(8):1288-1298. doi: 10.1016/j.jtho.2017.05.017. Epub 2017 May 30.
PubMed 28576745Ussavarungsi K, Kern RM, Roden AC, Ryu JH, Edell ES. Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Disease: Retrospective Analysis of 74 Cases. Chest. 2017 Feb;151(2):400-408. doi: 10.1016/j.chest.2016.09.002. Epub 2016 Sep 19.
PubMed 27660154Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
PubMed 23900983Imabayashi T, Uchino J, Yoshimura A, Chihara Y, Tamiya N, Kaneko Y, Yamada T, Takayama K. Safety and Usefulness of Cryobiopsy and Stamp Cytology for the Diagnosis of Peripheral Pulmonary Lesions. Cancers (Basel). 2019 Mar 22;11(3):410. doi: 10.3390/cancers11030410.
PubMed 30909479Jiang S, Liu X, Chen J, Ma H, Xie F, Sun J. A pilot study of the ultrathin cryoprobe in the diagnosis of peripheral pulmonary ground-glass opacity lesions. Transl Lung Cancer Res. 2020 Oct;9(5):1963-1973. doi: 10.21037/tlcr-20-957.
PubMed 33209616Izumo T, Sasada S, Chavez C, Tsuchida T. The diagnostic utility of endobronchial ultrasonography with a guide sheath and tomosynthesis images for ground glass opacity pulmonary lesions. J Thorac Dis. 2013 Dec;5(6):745-50. doi: 10.3978/j.issn.2072-1439.2013.11.30.
PubMed 24409350Ikezawa Y, Sukoh N, Shinagawa N, Nakano K, Oizumi S, Nishimura M. Endobronchial ultrasonography with a guide sheath for pure or mixed ground-glass opacity lesions. Respiration. 2014;88(2):137-43. doi: 10.1159/000362885. Epub 2014 Jul 2.
PubMed 24993187
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Transbronchial Cryobiopsy vs Forceps Biopsy in the Diagnosis of Lung Ground-glass Opacity: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04727190
- Acronym / sponsor ID
- SHCHE201904
- Conditions
- Lung Ground-Glass Opacity
- Keywords
- Lung Ground-Glass Opacity, Transbronchial Cryobiopsy, Forceps Biopsy, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Jan 2021 (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.
The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.
Detailed description
The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBCB group | Experimental | Procedure: Transbronchial CryobiopsySpecimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope. |
| TBFB group | Active comparator | Procedure: Transbronchial Forceps BiopsySpecimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged between 18 and 80.
- CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
- Thin-slice CT scan with bronchial access or adjacent lesions.
- Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
- It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
Key exclusion criteria (7 listed)
- Disseminated GGO, suspected of benign or infectious lesions.
- Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
- There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
- Intolerance or difficulty in cooperating with bronchoscopy, etc.
- Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
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 CryobiopsyThe eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy. | Procedure or surgery | TBCB group |
| Transbronchial Forceps BiopsyThe eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy. | Procedure or surgery | TBFB group |
Primary outcome
Diagnostic yield
Time frame: Up to 6 Months
Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.
1 secondary outcome
Tissue size
Time frame: Up to 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 28576745Heidinger BH, Anderson KR, Nemec U, Costa DB, Gangadharan SP, VanderLaan PA, Bankier AA. Lung Adenocarcinoma Manifesting as Pure Ground-Glass Nodules: Correlating CT Size, Volume, Density, and Roundness with Histopathologic Invasion and Size. J Thorac Oncol. 2017 Aug;12(8):1288-1298. doi: 10.1016/j.jtho.2017.05.017. Epub 2017 May 30.
- Background: PubMed 27660154Ussavarungsi K, Kern RM, Roden AC, Ryu JH, Edell ES. Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Disease: Retrospective Analysis of 74 Cases. Chest. 2017 Feb;151(2):400-408. doi: 10.1016/j.chest.2016.09.002. Epub 2016 Sep 19.
- Background: PubMed 23900983Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
- Background: PubMed 30909479Imabayashi T, Uchino J, Yoshimura A, Chihara Y, Tamiya N, Kaneko Y, Yamada T, Takayama K. Safety and Usefulness of Cryobiopsy and Stamp Cytology for the Diagnosis of Peripheral Pulmonary Lesions. Cancers (Basel). 2019 Mar 22;11(3):410. doi: 10.3390/cancers11030410.
- Background: PubMed 33209616Jiang S, Liu X, Chen J, Ma H, Xie F, Sun J. A pilot study of the ultrathin cryoprobe in the diagnosis of peripheral pulmonary ground-glass opacity lesions. Transl Lung Cancer Res. 2020 Oct;9(5):1963-1973. doi: 10.21037/tlcr-20-957.
- Background: PubMed 24409350Izumo T, Sasada S, Chavez C, Tsuchida T. The diagnostic utility of endobronchial ultrasonography with a guide sheath and tomosynthesis images for ground glass opacity pulmonary lesions. J Thorac Dis. 2013 Dec;5(6):745-50. doi: 10.3978/j.issn.2072-1439.2013.11.30.
- Background: PubMed 24993187Ikezawa Y, Sukoh N, Shinagawa N, Nakano K, Oizumi S, Nishimura M. Endobronchial ultrasonography with a guide sheath for pure or mixed ground-glass opacity lesions. Respiration. 2014;88(2):137-43. doi: 10.1159/000362885. Epub 2014 Jul 2.
- Individual participant dataSharing planned: No
Related trials for Lung Ground-Glass Opacity
Not yet recruitingObservational study
Deep Learning Time-Series Prediction of Long-Term Growth Patterns of Pulmonary Ground-Glass Nodules Using Serial CT
Pulmonary Nodules, Lung Neoplasms
RecruitingPhase 2
Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Lung Cancer
RecruitingPhase 2
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
Lung Adenocarcinoma
Recruiting
Cryoablation vs Thoracoscopic Surgery for GGN
Ground-Glass Opacity
Not yet recruiting
Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity
Pulmonary Nodules, Ground-glass Opacity
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.
Jiayuan Sun, MD, PhD study director
Shanghai Chest Hospital
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 Cryobiopsy and Transbronchial Forceps Biopsy in people with Lung Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
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 6 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 2 Feb 2021. 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 China. 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 Jiayuan Sun, MD, PhD (+86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: Up to 6 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 NCT04727190, which also lists 7 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 Feb 2021.