Lymph Node Disease
Conditions
Keywords
ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen
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.
Interventions
DEVICE22G-ProCore Endobronchial Ultrasound Needle
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
DEVICE22G-Standard Endobronchial Ultrasound Needle
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
Sponsors
Jiayuan Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of 22G-ProCore needle | up to 6 months | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. |
| Diagnostic yield of 22G-Standard needle | up to 6 months | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of histologic specimen used by 22G-ProCore needle | up to 6 months | The number and ratio of cellularity, blood contamination, and core-tissue acquisition. |
| The quality of histologic specimen used by 22G-Standard needle | up to 6 months | The number and ratio of cellularity, blood contamination, and core-tissue acquisition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of aspiration techniques | up to 6 months | 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. |
| Diagnostic yield of different agitations | up to 6 months | Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass. |
Countries
China
Contacts
Primary ContactJiayuan Sun, PhD
Outcome results
None listed