The Use and Effectiveness of Balloon for Endobronchial Ultrasonography

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Lung Cancer Staging

Treatments: Diagnostic Test: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT04735094

CT0101

Details and patient eligibility

About

Although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. Furthermore, it is uncertain whether this leads to a better diagnostic yield. To our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with EBUS. We hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.The aim of this study is to analyse whether the use of balloon during linear EBUS 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Adults aged ≥18 years
• Patient referred for EBUS guided TBNA of mediastinal LNs
• The para-tracheal lymph node (LN) station 4R is planned to be biopsied.

Exclusion criteria

-Patient referred for EBUS and 4R is NOT planned to be biopsed

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope

Experimental group

Treatment:

Diagnostic Test: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope

Endobronchial biopsy without the use of a balloon attached to the echo-bronchoscope

No Intervention group