Clinical trial NCT03575715: EBUS Image Features in the Diagnosis of PPLs
Official title: Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endobronchial Ultrasound
Keywords: endobronchial ultrasound
peripheral pulmonary lesions
image features
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The diagnostic value of EBUS image features
timeFrame: one year
Secondary outcomes:
measure: EBUS image features of adenocarcinoma
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Chest Hospital
name: Lei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chao TY, Lie CH, Chung YH, Wang JL, Wang YH, Lin MC. Differentiating peripheral pulmonary lesions based on images of endobronchial ultrasonography. Chest. 2006 Oct;130(4):1191-7. doi: 10.1378/chest.130.4.1191.
citation: Izumo T, Sasada S, Chavez C, Matsumoto Y, Tsuchida T. Radial endobronchial ultrasound images for ground-glass opacity pulmonary lesions. Eur Respir J. 2015 Jun;45(6):1661-8. doi: 10.1183/09031936.00167914. Epub 2015 Jan 8.
citation: Kurimoto N, Murayama M, Yoshioka S, Nishisaka T. Analysis of the internal structure of peripheral pulmonary lesions using endobronchial ultrasonography. Chest. 2002 Dec;122(6):1887-94. doi: 10.1378/chest.122.6.1887.
citation: Yasufuku K. Current clinical applications of endobronchial ultrasound. Expert Rev Respir Med. 2010 Aug;4(4):491-8. doi: 10.1586/ers.10.39.
citation: Travis WD, Rekhtman N, Riley GJ, Geisinger KR, Asamura H, Brambilla E, Garg K, Hirsch FR, Noguchi M, Powell CA, Rusch VW, Scagliotti G, Yatabe Y. Pathologic diagnosis of advanced lung cancer based on small biopsies and cytology: a paradigm shift. J Thorac Oncol. 2010 Apr;5(4):411-4. doi: 10.1097/JTO.0b013e3181d57f6e. No abstract available.