Peripheral Pulmonary Lesion
Conditions
Keywords
Ultrathin bronchoscope, Thin bronchoscope, Peripheral pulmonary lesion
Brief 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.
Interventions
PROCEDUREUltrathin bronchoscope
Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.
PROCEDUREThin bronchoscope
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.
PROCEDUREVirtual 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.
PROCEDUREGuide sheath
GS is a cannula with the thinnest outer diameter of 1.95 mm.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
West China Hospital
Henan Provincial People's Hospital
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Up to 6 months | Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of finding lesions | During the procedure | Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe |
| Feature of lesions | Up to 6 months | 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. |
| Total examination time | During the procedure | 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 |
| Difference in diagnostic yield | Up to 6 months | Difference in diagnostic yield between thin bronchoscope with guide sheath combined small biopsy forceps and without guide sheath combined with conventional biopsy forceps. |
| Complication rate | 1 month | The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation. |
| Difference in the bronchus level reached with the bronchoscope | During the procedure | 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 |
Countries
China
Outcome results
None listed