Diagnostic Value of UTB and TB for PPL

Study Overview
=================
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.

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

Conditions
-----------------
Peripheral Pulmonary Lesion

Intervention / Treatment
-----------------
* Procedure: Ultrathin bronchoscope
* Procedure: Thin bronchoscope
* Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound
* Procedure: Guide sheath


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UTB-VBN-EBUS group<br>Ultrathin bronchoscope with a 3.0-mm outer diameter and a 1.7-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN and EBUS. | Procedure: Ultrathin bronchoscope<br>* Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.<br>* Other names: UTB;Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound<br>* 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.<br>* Other names: VBN-EBUS;|
| Active Comparator: TB-VBN-EBUS-GS group<br>Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath. | Procedure: Thin bronchoscope<br>* Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.<br>* Other names: TB;Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound<br>* 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.<br>* Other names: VBN-EBUS;Procedure: Guide sheath<br>* GS is a cannula with the thinnest outer diameter of 1.95 mm.<br>* Other names: GS;|
| Active Comparator: TB-VBN-EBUS-non-GS group<br>Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using conventional biopsy forceps and cytology brush with the guidance of VBN and EBUS, but without guide sheath. | Procedure: Thin bronchoscope<br>* Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.<br>* Other names: TB;Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound<br>* 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.<br>* Other names: VBN-EBUS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During the procedure | 
| Duration of finding lesions | Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe | 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. | 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 | 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. | 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. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrathin bronchoscope, Thin bronchoscope, Peripheral pulmonary lesion