ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001110370p

Ethics application status

Submitted, not yet approved

Date submitted

4/08/2026

Date registered

8/09/2026

Date last updated

8/09/2026

Date data sharing statement initially provided

8/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Intranodal forceps and cryobiopsy for acquiring tissue from mediastinal lymph nodes during endobronchial ultrasound transbronchial nodal biopsy: A Randomised Controlled Study

Scientific title

Intranodal forceps and cryobiopsy for acquiring tissue from mediastinal lymph nodes during endobronchial ultrasound transbronchial nodal biopsy: A Randomised Controlled Study

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Lung cancer

Granulomatous disease

Lymphoma

Condition category

Condition code

Cancer

Lung - Non small cell

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

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.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Diagnosis / Prognosis

Description of the comparator or control

The participants will be randomized into different sequence of sampling during the same procedure. The initial sampling method and sequence of sampling will vary according to the study arms. All patients will have the same number and type of sampling method by the end of the procedure.

The primary outcome is to compare the diagnostic yield of EBUS-TBNA alone to EBUS-TBNA plus combined adjunctive sampling with EBUS-MCB and EBUS-IFB, using the American Thoracic Society (ATS) consensus definition of definitive diagnosis.

The control will be EBUS-TBNA

Control group

Active

Outcomes

Primary outcome [1]

To compare the diagnostic yield of EBUS-TBNA alone to EBUS-TBNA plus combined adjunctive sampling with EBUS-MCB and EBUS-IFB, using the American Thoracic Society (ATS) consensus definition of definitive diagnosis16, in patients with mediastinal or hilar lymphadenopathy.

Timepoint [1]

At the time of procedure.

Secondary outcome [1]

Overall diagnostic yield between techniques

Timepoint [1]

At the time of procedure.

Secondary outcome [2]

To evaluate and compare the rate of adverse events associated with each biopsy technique.

Assessment method [2]

Immediate adverse events observed during the procedure will be reported. There will be a follow up at 4 weeks to assess for delayed complications. Follow up will primarily be undertaken through review of medical records, including subsequent hospital presentations, admissions and relevant clinical documentation. Where necessary participants may be contacted by telephone. Complications include graded bleeding, pneumothorax, infection requiring antibiotics, unplanned admission, anaesthetic complications and death Severity will be described using the following categories: • Mild—the adverse event does not interfere with the volunteer’s daily routine and does not require intervention; it causes slight discomfort. • Moderate—the adverse event interferes with some aspects of the volunteer’s routine, or requires intervention, but is not damaging to health; it causes moderate discomfort. • Severe—the adverse event results in alteration, discomfort or disability which is clearly damaging to health. 2. Relationship to procedure — the assessment of relationship of AEs due to the procedure is a clinical decision based on all available information at the time of the completion of the CRF. The following categories will be used: • Definitely—there is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out. • Probably—there is evidence to suggest a causal relationship and the influence of other factors is unlikely. • Possibly—there is some evidence to suggest a causal relationship (e.g. the event occurred within a reasonable time after the procedure). However, the influence of other factors may have contributed to the event (i.e. the patient’s clinical condition, other concomitant events). • Unlikely—there is little evidence to suggest there is a causal relationship (e.g. the event did not occur within a reasonable time after the procedure). There is another reasonable explanation for the event (e.g. the patient’s clinical condition, other concomitant treatments). • Not related—there is no evidence of any causal relationship. • Not Assessable

Timepoint [2]

At the time of procedure and 4 weeks post-procedure

Secondary outcome [3]

Procedure time

Timepoint [3]

At the end of procedure

Secondary outcome [4]

Largest specimen size

Timepoint [4]

At the time of procedure

Secondary outcome [5]

To assess microbiology diagnostic yield for each biopsy modality where microbiological testing is performed

Timepoint [5]

At the time of procedure

Secondary outcome [6]

Proportion of patients who went on to have a subsequent biopsy to establish a diagnosis due to a non-diagnostic biopsy (by the 4 week follow up)

Timepoint [6]

Post procedure during 4 week follow up

Secondary outcome [7]

Sequence allocation comparison and feasibility: will compare the diagnostic yield between the two sequences and feasibility. It will determine the proportion of participants in whom both biopsy (IFB and MCB) techniques can be successfully performed according to the allocated sequence.

Timepoint [7]

At the time of procedure

Eligibility

Key inclusion criteria

Adults 18 years and older, undergoing linear EBUS for biopsy of mediastinal and/or hilar lymph node

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key 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.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

70 participants will be enrolled to detect 10% absolute difference in paired samples with a power of 80% at a 5% significance level. We aim to recruit 70 patients over a 12 month period.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

14/10/2026

Actual

Date of last participant enrolment

Anticipated

13/10/2027

Actual

Date of last data collection

Anticipated

10/11/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Hamza Azam (Western Sydney Local Health District)

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/07/2026

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dr Chinthaka Bhagya Samaranayake

Address

Department of Respiratory Medicine, Westmead hospital, Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7785

Fax

[email protected]

Contact person for public queries

Name

Hamza Azam

Address

Department of Respiratory Medicine, Westmead hospital, Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7785

Fax

[email protected]

Contact person for scientific queries

Name

Hamza Azam

Address

Department of Respiratory Medicine, Westmead hospital, Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7785

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically