EBUS Image Features in the Diagnosis of PPLs

Not Applicable

• Conditions: Endobronchial Ultrasound
• Interventions: Device: EBUS

• Registration Number: NCT03575715
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Study Start: 2018-07
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-02
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBUS group	EBUS	EBUS and guide sheath (GS) are inserted into bronchi in the assistance of navigation bronchoscopy. The EBUS probe and GS are confirmed to reach the lesion by EBUS images, cytologic and pathologic specimens are obtained with or without fluoroscopic guidance.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
EBUS image features of adenocarcinoma	one year	Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma