Clinical trial · Interventional
The Use and Effectiveness of Balloon for Endobronchial Ultrasonography
Randomized Control Trial of the Use and Effectiveness of Balloon for Endobronchial Ultrasonography.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Staging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope
- interventionNames
- Diagnostic Test: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope
- type
- NO_INTERVENTION
- label
- Endobronchial biopsy without the use of a balloon attached to the echo-bronchoscope
Primary outcomes (1)
- measure
- Diagnostic yield
- timeFrame
- 1 year
- description
- Diagnostic 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available