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

Shanghai Chest Hospital126 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

Lung Cancer

Interventions

VBNPROCEDURE

VBN is carried out by a VBN software（DirectPath;Olympus,Japan) which can automatically create virtual bronchoscopic images.

EBUSPROCEDURE

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.

X-rayPROCEDURE

The radiograph fluoroscopy is performed when the probe is confirmed to reach the lesion by EBUS image ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone

The diagnostic value means diagnostic yields in two groups for benign and malignant lesions

Time frame: Up to half year

Secondary Outcomes

The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone

The operation time means the total operation time and the total EBUS time.

Time frame: Up to half year

Data from ClinicalTrials.gov

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