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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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UTB-VBN-EBUS group

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.

Group Type EXPERIMENTAL

VBN

Intervention Type PROCEDURE

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

EBUS

Intervention Type PROCEDURE

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.

UTB-VBN-EBUS-X-ray group

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.

Group Type ACTIVE_COMPARATOR

VBN

Intervention Type PROCEDURE

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

EBUS

Intervention Type PROCEDURE

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-ray

Intervention Type PROCEDURE

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.

Interventions

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VBN

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

Intervention Type PROCEDURE

EBUS

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.

Intervention Type PROCEDURE

X-ray

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No