None listed
Conditions
Brief summary
This study aims to test the accuracy of two types of biopsy methods that is being proposed to get bigger sample of the lymph gland tissue used during the procedure. The first is by putting a pair of forceps (Intranodal Forceps Biopsy) through the airpipes into the lymph gland and removing a sample and the second is to put a freezing probe (Mini-Cryobiopsy) thought the airpipes into the lymph gland and removing a sample. We will compare samples we get using these techniques with what we usually do which is using a needle. Who is it for? You may be eligible for this study if you are male or female aged 18 years and older who are scheduled to undergo an EBUS procedure to biopsy enlarged lymph nodes in the chest (mediastinal and/or hilar lymph nodes). Study details All those who are eligible will undergo a standard EBUS procedure under general anaesthesia. During the procedure, tissue samples will be collected from the target lymph node using three biopsy methods: standard needle biopsy (EBUS-TBNA), intranodal forceps biopsy (EBUS-IFB), and mini-cryobiopsy (EBUS-MCB). All participants will receive all three biopsy methods. The order in which the forceps biopsy and mini-cryobiopsy are performed will be determined by chance (randomisation). The procedure is expected to take approximately 45 to 60 minutes and will be performed in the endoscopy unit of participating Australian hospitals. The collected tissue samples will undergo a range of laboratory tests, including cytology, histopathology, immunohistochemistry, molecular profiling, and, where required, microbiological testing and flow cytometry. It is hoped that this research will identify the most effective biopsy approach for diagnosing conditions that cause enlarged chest lymph nodes, helping patients receive an accurate diagnosis and appropriate treatment while reducing the need for additional procedures.
Interventions
Primary objective
To determine whether the addition of sequential EBUS-IFB and EBUS-MCB to standard EBUS-TBNA improves diagnostic yield compared with standard EBUS-TBNA alone
All procedures will be performed in the endoscopy unit of the approved sites in Australia. The bronchoscopist (respiratory physician or advanced trainee) will review the most recent CT Chest scan of the patient and determine the lymph node to be sampled
All participants will undergo a standard endobronchial ultrasound gui
Primary objective To determine whether the addition of sequential EBUS-IFB and EBUS-MCB to standard EBUS-TBNA improves diagnostic yield compared with standard EBUS-TBNA alone All procedures will be performed in the endoscopy unit of the approved sites in Australia. The bronchoscopist (respiratory physician or advanced trainee) will review the most recent CT Chest scan of the patient and determine the lymph node to be sampled All participants will undergo a standard endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) procedure under general anaesthesia using a linear EBUS bronchoscope. The target mediastinal and/or hilar lymph node will be biopsied with Standard EBUS-TBNA with a minimum of four needle passes. Participants will then be randomised to one of two biopsy sequences: (1) EBUS intranodal forceps biopsy (EBUS-IFB) followed by EBUS mini cryobiopsy (EBUS-MCB), or (2) EBUS-MCB followed by EBUS-IFB. Randomisation will be performed in a 1:1 allocation ratio using permuted block randomisation, stratified by participating site to either Sequence 1 or Sequence 2. Both adjunctive biopsy techniques will be performed through the existing EBUS needle tract, with up to 5 biopsy passes obtained using each technique. Mini cryobiopsy will be performed using a 1.1 mm cryoprobe with a freeze time of 3–6 seconds per biopsy. The transbronchial needle aspiration, mini cryobiopsy and intranodal forceops biopsy will be immediately after each other. All tissue specimens will be labelled and processed according to standard clinical practice for cytology, histopathology, immunohistochemistry and molecular profiling, microbiological testing (where indicated), flow cytometry (where indicated). Total procedure time is expected to be approximately 45–60 minutes.
Sponsors
Dr Hamza Azam (Western Sydney Local Health District)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults 18 years and older, undergoing linear EBUS for biopsy of mediastinal and/or hilar lymph node
Exclusion criteria
Exclusion criteria includes those unable to safely tolerate general anaesthesia, target lymph nodes <1cm in the short axis, uncorrectable coagulopathy and those unable to consent.
Outcome results
None listed