NCT03903471

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymph Node Disease

Interventions

Type	Name	Description
DEVICE	22G-ProCore Endobronchial Ultrasound Needle	EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
DEVICE	22G-Standard Endobronchial Ultrasound Needle	EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK

Timeline

• Start date: 2022-10-08
• Primary completion: 2023-10-08
• Completion: 2023-10-08
• First posted: 2019-04-04
• Last updated: 2022-09-29

Locations

1 site across 1 country: China