UTB-VBN-EBUS With or Without Fluoroscopy for the Diagnosis of PPLs

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: VBN; Procedure: EBUS; Procedure: X-ray

• Registration Number: NCT02664259
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Detailed Description

The investigators evaluate feasibility,efficacy and safety of UTB combined with VBN and EBUS for the diagnosis of PPLs without radiographic fluoroscopy.Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The final diagnoses are established by pathological evidence from biopsy or cytology specimen including bronchoscopy or other procedures,microbiological analysis and clinical follow-up.The study is designed as a single center prospective randomized controlled trial.The participating center is Department of endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.Subjects will be randomized (1:1) to UTB-VBN-EBUS-X-ray group and UTB-VBN-EBUS group based on a randomization schedule.The study is expected to enroll 200 patients with 100 patients of each group.

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Study Start: 2016-02
• Primary Completion: 2018-04
• Status Verified: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Patients with peripheral pulmonary lesions suspected to be cancer that need pathologically confirmed;
2. Presence of bronchus leading to or adjacent to the lesion from CT scan.

Exclusion Criteria

1. Pure ground glass opacity (GGO) lesions;
2. Refusal of participation;
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy;
4. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UTB-VBN-EBUS-X-ray group	VBN	Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.
UTB-VBN-EBUS-X-ray group	EBUS	Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.
UTB-VBN-EBUS group	VBN	Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.
UTB-VBN-EBUS group	EBUS	Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.
UTB-VBN-EBUS-X-ray group	X-ray	Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.

Primary Outcome Measures

Name	Time	Method
The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone	Up to half year	The diagnostic value means diagnostic yields in two groups for benign and malignant lesions

Secondary Outcome Measures

Name	Time	Method
The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone	Up to half year	The operation time means the total operation time and the total EBUS time.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China