EBUS Image Features in the Diagnosis of PPLs

Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03575715

Enrollment

200

Registered

2018-07-02

Start date

2018-07-31

Completion date

2019-12-31

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endobronchial Ultrasound

Keywords

endobronchial ultrasound, peripheral pulmonary lesions, image features

Brief summary

The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).

Detailed description

The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The investigator evaluates the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of EBUS image features in diagnosing PPLs. 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.

Interventions

DEVICEEBUS

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who are older than 18 year-old. 2. Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion 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. Absence of bronchus leading to or adjacent to the lesion from CT scan. 2. Refusal of participation. 3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy. 4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic value of EBUS image features	one year	The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate.

Secondary

Measure	Time frame	Description
EBUS image features of adenocarcinoma	one year	Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma

Contacts

Primary ContactLei Wang, MD

13917985547@163.com86-021-22200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026