Clinical trial NCT04727190: The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Ground-Glass Opacity
Keywords: Lung Ground-Glass Opacity
Transbronchial Cryobiopsy
Forceps Biopsy
Diagnosis
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
First posted: 2021-01-27
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged between 18 and 80.
2. CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
3. Thin-slice CT scan with bronchial access or adjacent lesions.
4. Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
5. It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
6. Ability to read, understand and sign ICF.

Exclusion Criteria:

1. Disseminated GGO, suspected of benign or infectious lesions.
2. Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
3. There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
4. Intolerance or difficulty in cooperating with bronchoscopy, etc.
5. Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
6. Vulnerable groups, such as pregnant women, etc.
7. Some other special situations investigator consider subjects are not suitable to participant in this study.

Primary outcomes:
measure: Diagnostic yield
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Tissue size
timeFrame: Up to 1 months
Other outcomes:
measure: Sampling time
timeFrame: Up to 1 months
measure: Number of sampling and effective sampling
timeFrame: Up to 1 months
measure: Quality of specimens
timeFrame: Up to 6 months
measure: Adverse events
timeFrame: Up to 1 months
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.