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

Not Applicable

• Conditions: Lung Ground-Glass Opacity
• Interventions: Procedure: Transbronchial Cryobiopsy; Procedure: Transbronchial Forceps Biopsy

• Registration Number: NCT04727190
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Study First Submitted: 2020-03-15
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-27
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02
• Study Start: 2021-03-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBCB group	Transbronchial Cryobiopsy	Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope.
TBFB group	Transbronchial Forceps Biopsy	Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	Up to 6 Months	Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.

Secondary Outcome Measures

Name	Time	Method
Tissue size	Up to 1 months	The maximum diameter measured by the biopsy tissue.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China