ENB in the Diagnosis of Peripheral Pulmonary Nodules

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2019-12-30

Brief Summary

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The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

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Detailed Description

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The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Conditions

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Peripheral Pulmonary Nodules

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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ENB-EBUS-GS group

ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

Group Type EXPERIMENTAL

ENB

Intervention Type DEVICE

ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

EBUS-GS

Intervention Type DEVICE

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 and a GS (K-201; Olympus).

EBUS-GS group

ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

Group Type ACTIVE_COMPARATOR

EBUS-GS

Intervention Type DEVICE

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 and a GS (K-201; Olympus).

Interventions

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ENB

ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

Intervention Type DEVICE

EBUS-GS

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 and a GS (K-201; Olympus).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients who are older than 18 year-old.
2. Chest CT shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No