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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymph Node Disease
• Intervention / Treatment: Device: 22G-ProCore Endobronchial Ultrasound Needle; Device: 22G-Standard Endobronchial Ultrasound Needle

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 22G-ProCore Group; The 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.	Device: 22G-ProCore Endobronchial Ultrasound Needle; EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
Active Comparator: 22G-Standard Group; The 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.	Device: 22G-Standard Endobronchial Ultrasound Needle; EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jiayuan Sun

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 8, 2022
• Primary Completion (Anticipated): October 8, 2023
• Study Completion (Anticipated): October 8, 2023

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: ProCore; Mediastinal and Hilar Lymphadenopathy; EBUS-TBNA; Diagnostic Yield; Quality of Specimen
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: SHCHE201901

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
• product manufactured in and exported from the U.S.: No