EBUS Image Features in the Diagnosis of PPLs

Endobronchial Ultrasound Clinical Trial

Official title:

Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03575715
• Other study ID #: Chest007
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Shanghai Chest Hospital
• Contact: Lei Wang, MD
• Phone: 86-021-22200000
• Email: 13917985547[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endobronchial Ultrasound

Intervention

Device:
• 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 and a GS (K-201; Olympus).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic value of EBUS image features	The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate.	one year
Secondary	EBUS image features of adenocarcinoma	Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma	one year