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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03903471
Study type Interventional
Source Shanghai Chest Hospital
Contact Jiayuan Sun, PhD
Phone +86-021-22200000
Email jysun1976@163.com
Status Recruiting
Phase N/A
Start date October 8, 2022
Completion date October 8, 2023
View Details
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