A feasibility study comparing the safety and acceptability of vacuum-assisted biopsy and conventional 14-gauge core biopsy in the diagnosis of ultrasonically indeterminate and abnormal axillary lymph nodes

ISRCTN	ISRCTN71623770
DOI	https://doi.org/10.1186/ISRCTN71623770
Secondary identifying numbers	14676

Submission date: 12/06/2014
Registration date: 12/06/2014
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-two-ways-taking-samples-tissue-lymph-nodes-under-arm

Contact information

Miss Tania Cutts
Scientific

University of Manchester
Nightingale Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	tania.cutts@uhsm.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A feasibility study comparing the safety and acceptability of vacuum-assisted biopsy and conventional 14-gauge core biopsy in the diagnosis of ultrasonically indeterminate and abnormal axillary lymph nodes
Study objectives	Women with invasive breast cancer undergo ultrasound of the axilla (armpit) before surgery to detect spread of disease (metastases) to the lymph nodes. If this is normal the woman undergoes operative sentinel lymph node biopsy (SLNB), usually at the same time as surgery to the breast. If the SLNB is positive the woman undergoes axillary node clearance at a subsequent operation. Abnormal axillary lymph nodes on ultrasound undergo needle sampling. If metastases are confirmed the woman undergoes node clearance at the same operation as surgery to the breast. The number of women who need to undergo more than one operation can be minimised by maximising the number of women with axillary metastatic disease who are diagnosed before surgery. Ultrasound has a sensitivity of ~60% for the detection of metastatic lymph nodes. Ultrasound-guided biopsy of nodes that contain metastases has a sensitivity of ~80%. This is less than 100% because the needle may miss the part of the lymph node containing the tumour deposit. Increasing the volume of tissue removed may increase accuracy. Vacuum-assisted biopsy (VAB) is a needle technique performed under local anaesthetic which allows more tissue to be removed than with a standard needle. Repeated samples can be taken with a single needle insertion, allowing large numbers of samples to be quickly taken. VAB of breast abnormalities is well tolerated by patients. This study will determine whether the use of VAB in the axilla is safe and acceptable to patients and whether a larger randomised study comparing the two techniques is feasible. The results will inform the design of a larger study which will determine whether VAB significantly increases the preoperative diagnosis rate of axillary metastatic disease. If it does, its use will result in a reduction in the number of second operations in women with breast cancer.
Ethics approval(s)	13/NW/0326
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Intervention	Participants randomised to have axillary lymph node biopsy with either 14-gauge core needle biopsy device or a 13-gauge or 10-gauge vacuum biopsy device. Study Entry : Registration only
Intervention type	Other
Primary outcome measure	Proportion of women who would be willing to undergo the biopsy again.; Timepoint(s): 4 to 14 days post-biopsy
Secondary outcome measures	1. Procedure pain scores; Timepoint(s): Immediate and at 4-14 days post-biopsy 2. Proportion of women approached who are willing to enter the study.; Timepoint(s): AT recruitment 3. The sensitivity of vacuum biopsy relative to conventional core biopsy (preliminary data only); Timepoint(s): Following surgery
Overall study start date	20/06/2013
Completion date	17/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 80; UK Sample Size: 80
Total final enrolment	80
Key inclusion criteria	1. Women in screening and symptomatic clinics aged >35 years with breast masses scored as: 1.1. M4 or M5 (mammographically suspicious or highly suspicious of malignancy) and U5 (ultrasonically highly suspicious of malignancy) 1.2. and/or MRI5 (highly suspicious of malignancy on MRI) and U5 1.3. and/or have histologically proven breast cancer 1.4. and who have ultrasonically indeterminate or abnormal ipsilateral axillary lymph nodes (i.e. suspicious of metastatic disease) 2. Indeterminate / abnormal lymph nodes are defined as those with >2.3mm lymphoid thickness and/or focal cortical bulging and/or non-hilar blood flow and/or loss or reduction in the normal hilar fat
Key exclusion criteria	1. Women who are on anticoagulants or have known clotting disorders 2. Previous ipsilateral axillary surgery 3. Target lymph node not suitable for vacuum biopsy due to its proximity to critical structures such as major blood vessels
Date of first enrolment	20/06/2013
Date of final enrolment	17/06/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester NHS Foundation Trust (UK)
Hospital/treatment centre

Wythenshawe Hospital, Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

"ROR"	https://ror.org/00he80998

Funders

Funder type

Charity

British Society of Breast Radiology (BSBR) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2016	11/07/2019	Yes	No
Plain English results			26/10/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
11/07/2019: Publication reference and total final enrolment added.
29/03/2017: No publications found, verifying study status with principal investigator.