NCT02906280

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

Randomized Controlled Trial Comparing the Performance of 19 Gauge Versus 22 Gauge EBUS-TBNA Needles in Lung Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Lung Neoplasm

Interventions

Type	Name	Description
DEVICE	EBUS-TBNA needle	tissue sampling

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2016-09-20
• Last updated: 2016-09-20

Locations

1 site across 1 country: Belgium