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Randomised controlled trial comparing the diagnostic yield of initial forceps biopsy vs brushings in Radial Guide Sheath Endobronchial Ultrasound lung biopsy

Randomised controlled trial comparing the diagnostic yield of initial forceps biopsy vs brushings in Radial Guide Sheath Endobronchial Ultrasound lung biopsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000790246
Enrollment
22
Registered
2018-05-10
Start date
2018-06-04
Completion date
2019-05-01
Last updated
2018-09-10

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

Conditions

None listed

Brief summary

Radial guide sheath endobronchial ultrasound (EBUS) is one of the bronchoscopic modalities commonly used for obtaining lung biopsies. This technique utilises both biopsy forceps and brushings to obtain tissue samples. The main objective of this study is to determine whether the sequence of sampling in this procedure affect the diagnostic yield. Who is it for? You may be eligible for this study if you are booked for a radial guide sheath endobronchial ultrasound (EBUS) at Sunshine Coast University Hospital. Study details All participants will be biopsied with both types of sampling methods in a randomised order. The samples obtained will be analysed as per the usual practice. There are no additional tests or assessments for the participants other than what is involved in the usual clinical care. It is hoped this study will provide evidence to guide the optimal sequence of sampling during this lung biopsy procedures.

Interventions

The radial guide sheath endobronchial ultrasound guided lung biopsies will be performed as per the usual practice at Sunshine Coast University Hospital utilising the usual equipment used for the procedure (Olympus BF190 or Olympus BF3C20 bronchoscope). - All procedures will be performed in the endoscopy unit at Sunshine Coast University. The bronchoscopist (respiratory physician or advanced trainee) will review the most recent CT Chest scan of the patient and determine the sub-segmental anato

The radial guide sheath endobronchial ultrasound guided lung biopsies will be performed as per the usual practice at Sunshine Coast University Hospital utilising the usual equipment used for the procedure (Olympus BF190 or Olympus BF3C20 bronchoscope). - All procedures will be performed in the endoscopy unit at Sunshine Coast University. The bronchoscopist (respiratory physician or advanced trainee) will review the most recent CT Chest scan of the patient and determine the sub-segmental anatomical location of the lesions to be sampled. - Bronchoscopy will be performed under a general anaesthetic with the bronchoscope passed through a laryngeal mask airway and less commonly through an endotracheal tube, at the discretion of the anaesthetist. - The airways will be examined to segmental and sub-segmental level bilaterally. - Once the bronchoscope is in predetermined sub-segmental airway and cannot be advanced any further, the radial EBUS probe covered with the guide sheath is advanced though the working channel of the bronchoscope towards the lesion. The radial EBUS provides a high resolution 360 degree view of the surrounding lung. The usual characteristic ultrasound features of normal and abnormal lung tissue will be used to identify the lesion. Once the lesion is located, the radial EBUS probe is withdrawn while the guide sheath is left in place as an extended working channel. The sampling instruments (biopsy forceps and brush) are then advanced through the guide sheath to the lesion to obtain tissue samples. The sampling sequence will be randomly allocated prior to the procedure. The study arms are: A1) 6 forceps biopsies and 2 brushings A2) 3 forceps biopsies and 2 brushings and 3 forceps biopsies B) 2 brushings and 6 forceps biopsies. - All the collected specimens will be labelled and sent to the Sunshine Coast University Hospital laboratory for processing as per usual practice. The laboratory staff will receive the standard specimen jars: o All forceps biopsy specimens in a formalin jar o Brushings smeared on slides and the brush tip in a formalin jar o Washings in a specimen jar. - The usual procedure time is 30 minutes.

Sponsors

Dr Chinthaka Samaranayake
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

All patients booked and consented for a radial guide sheath EBUS at Sunshine Coast University Hospital by the treating respiratory physician will be eligible to participate in the study

Exclusion criteria

- Radial guide sheath EBUS of the same lesion within 2 weeks prior to enrolment. - Lesion size <1.5cm in the long axis on the most recent CT scan prior to the procedure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026