RCT Comparing 19Ga vs 22Ga EBUS-TBNA Needles in Carcinoma.

Catholic University (KU) of Leuven

Status and phase: Unknown; Phase 3

Conditions: Lung Neoplasm

Treatments: Device: EBUS-TBNA needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02906280

S58667

Details and patient eligibility

About

EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

Full description

All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
• requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis

Exclusion criteria

• uncontrolled coagulopathy
• tracheal stenosis

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

19 Ga EBUS-TBNA needle

Experimental group

Description:

needle aspiration by a flexible 19 Ga needle (Olympus)

Treatment:

Device: EBUS-TBNA needle

22 Ga EBUS-TBNA needle

Active Comparator group

Description:

needle aspiration by a 22 Ga needle (Olympus)

Treatment:

Device: EBUS-TBNA needle