The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO

NCT ID: NCT04727190

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-30

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.

Conditions

Lung Ground-Glass Opacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

TBCB group

Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope.

Group Type: EXPERIMENTAL

Transbronchial Cryobiopsy

Intervention Type: PROCEDURE

The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.

TBFB group

Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope.

Group Type: ACTIVE_COMPARATOR

Transbronchial Forceps Biopsy

Intervention Type: PROCEDURE

The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.

Interventions

Transbronchial Cryobiopsy

The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.

Intervention Type: PROCEDURE

Transbronchial Forceps Biopsy

The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Director, Department of Respiratory Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Sun, MD, PhD

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jiayuan Sun, MD, PhD

Role: CONTACT

xkyyjysun@163.com

+86-021-22200000 ext. 1511

Facility Contacts

Jiayuan Sun, MD,PhD

Role: primary

xkyyjysun@163.com

+86-021-22200000 ext. 1511

References

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.

Reference Type: BACKGROUND

PMID: 28576745 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27660154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23900983 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30909479 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33209616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24409350 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24993187 (View on PubMed)

Other Identifiers

SHCHE201904

Identifier Type: -

Identifier Source: org_study_id