UnknownNot Applicable

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

China600 participantsStarted 2022-10-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Diagnostic yield of 22G-ProCore needle

Timeframe: up to 6 months

Diagnostic yield of 22G-Standard needle

Timeframe: up to 6 months

Trial details

NCT IDNCT03903471

SponsorJiayuan Sun

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-08

Contact for this trial

Jiayuan Sun, PhD

+86-021-22200000 jysun1976@163.com

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