Diagnostic Value of UTB and TB for PPL

Shanghai Chest Hospital578 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

578

Conditions

Peripheral Pulmonary Lesion

Interventions

Ultrathin bronchoscopePROCEDURE

Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.

Thin bronchoscopePROCEDURE

Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.

Virtual bronchoscopic navigation combined with endobronchial ultrasoundPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years old. * Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 5 cm. * Patients without contraindications of bronchoscopy. * Patients have good medical adherence and signed informed consent. Exclusion Criteria: * Peripheral pulmonary lesion is pure ground-glass opacity. * Absence of bronchus leading to or adjacent to the lesion on thin-slice chest CT. * Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus). * Diffuse pulmonary lesions. * The investigators believe that patient has other conditions that are not suitable for the study.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Diagnostic yield

Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions

Time frame: Up to 6 months

Secondary Outcomes

Total examination time

Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination

Time frame: During the procedure

Duration of finding lesions

Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe

Time frame: During the procedure

Feature of lesions

The feature of peripheral pulmonary lesions affecting the diagnostic yield includes the nature, size, location, the position of the ultrasound probe relative to the lesions etc.

Time frame: Up to 6 months

Difference in the bronchus level reached with the bronchoscope

Level: Bronchus is level 0, leaf bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3

Time frame: During the procedure

Difference in diagnostic yield

Difference in diagnostic yield between thin bronchoscope with guide sheath combined small biopsy forceps and without guide sheath combined with conventional biopsy forceps.

Time frame: Up to 6 months

Complication rate

The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation.

Data from ClinicalTrials.gov

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