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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBCB group | Experimental | Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope. |
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| TBFB group | Active Comparator | Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transbronchial Cryobiopsy | Procedure | The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity. | Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue size | The maximum diameter measured by the biopsy tissue. | Up to 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sampling time | The time spent in sampling the lesions begins with the insertion of biopsy tools into the bronchoscope work channel, and ends with the insertion of all biopsy specimens for the target lesion into the specimen bottle. | Up to 1 months |
| Number of sampling and effective sampling |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | +86-021-22200000 | 1511 | xkyyjysun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28576745 | Background | 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. | |
| 27660154 |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Transbronchial Forceps Biopsy | Procedure | The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy. |
|
The operation for biopsy purposes is taken as one sampling, whether the sample is obtained or not, and if the sample is obtained, record as effective sampling. |
| Up to 1 months |
| Quality of specimens | On the premise that other sample processing processes are fixed, different sampling methods will have different effects on the samples. To obtain abnormal lung tissues as eligible samples, the integrity of tissue morphology and structure preservation is an important factor in evaluating the quality of tissue samples. | Up to 6 months |
| Adverse events | To evaluate the bleeding in the biopsy site mainly, which is one of the main complications of bronchoscopy biopsy. Adverse events shall be judged in accordance with relevant regulations, and serious adverse events shall be recorded and reported in accordance with regulations. | Up to 1 months |
| Ussavarungsi 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. |
| 23900983 | Background | Schuhmann 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. |
| 30909479 | Background | Imabayashi 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. |
| 33209616 | Background | Jiang 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. |
| 24409350 | Background | Izumo 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. |
| 24993187 | Background | Ikezawa 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. |