- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575715
EBUS Image Features in the Diagnosis of PPLs
June 29, 2018 updated by: Xu Lei, Shanghai Chest Hospital
Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions
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).
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are older than 18 year-old.
- 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.
- Patients who agree to undergo bronchoscopy without any contraindications.
- Patients who have good compliance and sign informed consent.
Exclusion Criteria:
- Absence of bronchus leading to or adjacent to the lesion from CT scan.
- Refusal of participation.
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
- Presence of concomitant endobronchial lesion during the bronchoscopy procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EBUS group
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The diagnostic value of EBUS image features
Time Frame: one year
|
The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EBUS image features of adenocarcinoma
Time Frame: one year
|
Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Yasufuku K. Current clinical applications of endobronchial ultrasound. Expert Rev Respir Med. 2010 Aug;4(4):491-8. doi: 10.1586/ers.10.39.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2018
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
June 29, 2018
First Posted (ACTUAL)
July 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 29, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Chest007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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