An interventional study of Ultrathin bronchoscope and Thin bronchoscope in Peripheral Pulmonary Lesion, sponsored by Shanghai Chest Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic
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.
Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
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Exclusion Criteria:
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 · Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound
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 · Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound · Procedure: Guide sheath
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 · Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound
Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.
Also known as: UTB
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.
Also known as: TB
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.
Also known as: VBN-EBUS
GS is a cannula with the thinnest outer diameter of 1.95 mm.
Also known as: GS
Diagnostic yield
Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions
Time frame: Up to 6 months
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.
Time frame: 1 month
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital