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

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02906280
• Other study ID #: S58667
• Status: Recruiting
• Phase: Phase 3
• First received: May 27, 2016
• Last updated: September 19, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Katholieke Universiteit Leuven
• Contact: Christophe Dooms
• Email: christophe.dooms[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Device:
• EBUS-TBNA needle
tissue sampling

Locations

Country	Name	City	State
Belgium	University Hospitals KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue core	Descriptive tissue characteristics of tumor sample	14 months	No
Secondary	Tumor cellularity per area of diagnostic tissue	Objective pathologic measurement of tumor density	14 months	No
Secondary	Quantity of DNA extracted	Objective measurement of the amount of DNA	14 months	No
Secondary	Success rate of Next Generation Sequencing	Feasibility of NGS testing	14 months	No