22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA
Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial
1 other identifier
interventional
600
1 country
1
Brief Summary
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 4, 2019
CompletedStudy Start
First participant enrolled
October 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2023
CompletedSeptember 29, 2022
September 1, 2022
1 year
March 31, 2019
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic yield of 22G-ProCore needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
up to 6 months
Diagnostic yield of 22G-Standard needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
up to 6 months
Secondary Outcomes (2)
The quality of histologic specimen used by 22G-ProCore needle
up to 6 months
The quality of histologic specimen used by 22G-Standard needle
up to 6 months
Other Outcomes (2)
Diagnostic yield of aspiration techniques
up to 6 months
Diagnostic yield of different agitations
up to 6 months
Study Arms (2)
22G-ProCore Group
EXPERIMENTALThe experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle.
22G-Standard Group
ACTIVE COMPARATORThe control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle.
Interventions
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
Eligibility Criteria
You may qualify if:
- Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter \> 1 cm in CT or PET-CT SUV value \> 2.5).
- Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
- Inform consent signed.
You may not qualify if:
- Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count \< 50000 or INR \> 1.5).
- Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
- Life expectancy less than 6 months.
- Uncooperative patients.
- Patients representing vulnerable populations (prisoners, pregnant women, etc).
- Researchers consider it inappropriate to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jiayuan Sunlead
Study Sites (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Related Publications (5)
Stamatis G. Staging of lung cancer: the role of noninvasive, minimally invasive and invasive techniques. Eur Respir J. 2015 Aug;46(2):521-31. doi: 10.1183/09031936.00126714. Epub 2015 May 14.
PMID: 25976686BACKGROUNDSun J, Zhang J, Zhao H, Shen J, Gu A, Han B. Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Thorac Cancer. 2010 May;1(1):28-34. doi: 10.1111/j.1759-7714.2010.00010.x.
PMID: 27755785BACKGROUNDSun J, Teng J, Yang H, Li Z, Zhang J, Zhao H, Garfield DH, Han B. Endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing intrathoracic tuberculosis. Ann Thorac Surg. 2013 Dec;96(6):2021-7. doi: 10.1016/j.athoracsur.2013.07.005. Epub 2013 Sep 12.
PMID: 24035300BACKGROUNDSun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12.
PMID: 25497069BACKGROUNDYang H, Wang S, Teng J, Han B, Sun J. Utility of endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing non-specific inflammatory intrathorcacic lymphadenitis. Clin Respir J. 2018 Feb;12(2):691-698. doi: 10.1111/crj.12580. Epub 2016 Nov 23.
PMID: 27882677BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jiayuan Sun, MD,PhD
Shanghai Chest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Department of Respiratory Endoscopy and Interventional Pulmonology, Shanghai Chest Hospital
Study Record Dates
First Submitted
March 31, 2019
First Posted
April 4, 2019
Study Start
October 8, 2022
Primary Completion
October 8, 2023
Study Completion
October 8, 2023
Last Updated
September 29, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share