Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens

Maggiore Bellaria Hospital, Bologna

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Other: Rapid on-site evaluation; Device: EBUS-TBNA

Study type: Interventional

Funder types: Other

Identifiers

NCT01799382

13001-Trisolini

Details and patient eligibility

About

The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.

Enrollment: 126 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion criteria

• Pregnancy
• Uncontrolled coagulopathy
• Refusal to sign informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

EBUS-TBNA + Rapid on-site evaluation

Experimental group

Description:

Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA

Treatment:

Other: Rapid on-site evaluation

Device: EBUS-TBNA

EBUS-TBNA

Active Comparator group

Description:

Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation

Treatment:

Device: EBUS-TBNA