NCT04571476

Diagnostic Value of UTB and TB for PPL

Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 578 (actual)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy.

Detailed description

The study aims to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy. The study is designed as a prospective, multicenter, randomized controlled clinical trial. The participating centers are The First Affiliated Hospital of Guangzhou Medical University, Cancer Hospital Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, and Henan Provincial People's Hospital. Patients are divided into three groups: UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group. Each subject will be randomized to each group. The study is expected to enroll a total of 577 patients with 193, 192 and 192 in UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group, respectively.

Conditions

• Peripheral Pulmonary Lesion

Interventions

Type	Name	Description
PROCEDURE	Ultrathin bronchoscope	Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.
PROCEDURE	Thin bronchoscope	Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.
PROCEDURE	Virtual bronchoscopic navigation combined with endobronchial ultrasound	VBN can create a path to the target lesion automatically when the lesion is depicted in this software.VBN combined with EBUS can improve the diagnostic yield of PPL and shorten the examination time, which has become the standard method for the diagnosis of PPL.
PROCEDURE	Guide sheath	GS is a cannula with the thinnest outer diameter of 1.95 mm.

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-01-07
• Completion: 2022-07-31
• First posted: 2020-10-01
• Last updated: 2023-09-06

Locations

1 site across 1 country: China