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

Jiayuan Sun

Status: Enrolling

Conditions: Lymph Node Disease

Treatments: Device: 22G-Standard Endobronchial Ultrasound Needle; Device: 22G-ProCore Endobronchial Ultrasound Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT03903471

SHCHE201901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

22G-ProCore Group

Experimental group

Description:

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.

Treatment:

Device: 22G-ProCore Endobronchial Ultrasound Needle

22G-Standard Group

Active Comparator group

Description:

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.

Treatment:

Device: 22G-Standard Endobronchial Ultrasound Needle