NCT04727190

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

The Efficacy and Safety of Transbronchial Cryobiopsy vs Forceps Biopsy in the Diagnosis of Lung Ground-glass Opacity: A Prospective, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Transbronchial Cryobiopsy	The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.
PROCEDURE	Transbronchial Forceps Biopsy	The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-09-30
• Completion: 2021-12-30
• First posted: 2021-01-27
• Last updated: 2021-02-02

Locations

1 site across 1 country: China