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

Phase 3

• Conditions: Lung Neoplasm
• Interventions: Device: EBUS-TBNA needle

• Registration Number: NCT02906280
• Lead Sponsor: KU Leuven

Brief 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-27
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-19
• Last Update Submitted: 2016-09-19
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22 Ga EBUS-TBNA needle	EBUS-TBNA needle	needle aspiration by a 22 Ga needle (Olympus)
19 Ga EBUS-TBNA needle	EBUS-TBNA needle	needle aspiration by a flexible 19 Ga needle (Olympus)

Primary Outcome Measures

Name	Time	Method
Tissue core	14 months	Descriptive tissue characteristics of tumor sample

Secondary Outcome Measures

Name	Time	Method
Tumor cellularity per area of diagnostic tissue	14 months	Objective pathologic measurement of tumor density
Quantity of DNA extracted	14 months	Objective measurement of the amount of DNA
Success rate of Next Generation Sequencing	14 months	Feasibility of NGS testing

Trial Locations

Locations (1)

University Hospitals KU Leuven; 🇧🇪 Leuven, Belgium