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

NCT ID: NCT02906280

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Lung Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

19 Ga EBUS-TBNA needle

needle aspiration by a flexible 19 Ga needle (Olympus)

Group Type: EXPERIMENTAL

EBUS-TBNA needle

Intervention Type: DEVICE

tissue sampling

22 Ga EBUS-TBNA needle

needle aspiration by a 22 Ga needle (Olympus)

Group Type: ACTIVE_COMPARATOR

EBUS-TBNA needle

Intervention Type: DEVICE

tissue sampling

Interventions

EBUS-TBNA needle

tissue sampling

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Christophe Dooms, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals KU Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Christophe Dooms

Role: CONTACT

christophe.dooms@uzleuven.be

Facility Contacts

Marc Decramer

Role: primary

marc.decramer@uzleuven.be

Other Identifiers

S58667

Identifier Type: -

Identifier Source: org_study_id