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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Lymph Node Disease

Intervention / Treatment
-----------------
* Device: 22G-ProCore Endobronchial Ultrasound Needle
* Device: 22G-Standard Endobronchial Ultrasound Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 22G-ProCore Group<br>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<br>* EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK<br>|
| Active Comparator: 22G-Standard Group<br>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<br>* EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen