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The Use and Effectiveness of Balloon for Endobronchial Ultrasonography

Randomized Control Trial of the Use and Effectiveness of Balloon for Endobronchial Ultrasonography.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04735094
Enrollment
46
Registered
2021-02-02
Start date
2021-01-21
Completion date
2021-05-17
Last updated
2022-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Staging

Brief summary

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.

Interventions

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

A small balloon made of latex can be attached to the tip of echo-bronchoscope which is then inflated with water or saline for better apposition of the echo-endoscope and the airway wall. This may improve ultrasound image quality and aid better visualization of the lymph nodes.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield1 yearDiagnostic yield will be calculated separately for each group with and without the use of balloon. Diagnostic yield will be defined as a satisfactory sample with presence of lymphocytes in the aspirate on the final pathology report. In order to minimise the confounding factor in diagnostic yield based on the dimensions of the LN, we chose a single LN station (4R) and patients were sub-dvided into 3 groups based on the size of the LN.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026