22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA

Lymph Node Disease Clinical Trial

Official title:

Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03903471
• Other study ID #: SHCHE201901
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: October 8, 2023

Study information

• Verified date: September 2022
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, PhD
• Phone: +86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 8, 2023
• Est. primary completion date: October 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.

3. Inform consent signed.

Exclusion Criteria:

1. Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5).

2. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.

3. Life expectancy less than 6 months.

4. Uncooperative patients.

5. Patients representing vulnerable populations (prisoners, pregnant women, etc).

6. Researchers consider it inappropriate to participate in this study.

Related Conditions & MeSH terms

• Lymph Node Disease
• Lymphadenopathy

Intervention

Device:
• 22G-ProCore Endobronchial Ultrasound Needle
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
• 22G-Standard Endobronchial Ultrasound Needle
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

Sun 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. — View Citation

Sun 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. Erratum in: Ann Thorac Surg. 2015 Jun;99(6):2257. — View Citation

Sun 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. — View Citation

Yang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic yield of aspiration techniques	Conventional EBUS-TBNA procedures involve use of 10mL negative suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure.	up to 6 months
Other	Diagnostic yield of different agitations	Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass.	up to 6 months
Primary	Diagnostic yield of 22G-ProCore needle	Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.	up to 6 months
Primary	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	The quality of histologic specimen used by 22G-ProCore needle	The number and ratio of cellularity, blood contamination, and core-tissue acquisition.	up to 6 months
Secondary	The quality of histologic specimen used by 22G-Standard needle	The number and ratio of cellularity, blood contamination, and core-tissue acquisition.	up to 6 months