A study comparing two ways of taking samples of tissue from lymph nodes under the arm

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Cancer type:

Breast cancer

Status:

Results

Phase:

Pilot

This study compared core needle biopsies and vacuum assisted biopsies for taking samples of tissue from lymph nodes under the arm.

More about this trial

Lymph nodes are a part of the lymphatic system. They help clear waste products and damaged cells from the body. 
 
Sometimes cancer cells break away from the original cancer, and get stuck in the nearest lymph nodes. So doctors often check the lymph nodes closest to the cancer. They usually check the lymph nodes under the arm of people diagnosed with breast cancer.
 
When this study was done, doctors usually did an ultrasound scan and then took samples of lymph node tissue (a biopsy) using a hollow needle. This is called a core needle biopsy (CNB)
 
Another way of taking a biopsy is a vacuum assisted biopsy (VAB). The doctor still puts a needle into the lymph node, but it’s attached to a special vacuum device. They can take slightly larger samples of tissue this way.  
 
The research team wanted to compare vacuum assisted biopsies with core needle biopsies for taking samples of tissue from lymph nodes.
 
The aims of this study were to find out whether:
  • vacuum assisted biopsies were safe and acceptable to patients
  • it would be possible to do a larger study to compare vacuum assisted biopsies with core needle biopsies

Summary of results

The study team found that vacuum assisted biopsies were acceptable and that it should be possible to do a larger trial.
 
This study was open for people to join between 2013 and 2015, and the research team reported the results in 2016.
 
About this study
The women in this pilot study all had breast cancer and were due to have surgery. As part of this study they had either a core needle biopsy (CNB) or vacuum assisted biopsy (VAB) of the lymph nodes under their arm. They then had surgery to remove their breast cancer and lymph nodes.
 
The research team asked 95 women if they would like to take part in this study, and 81 women (85%) agreed. 
 
Of these, 80 were able to take part and were put into 1 of 2 groups at random:
  • 40 had a core needle biopsy (CNB)
  • 40 had a vacuum assisted biopsy (VAB)

Results
The research team looked at the tissue removed during the biopsies and the lymph nodes removed during surgery, to see whether they contained any cancer cells.
 
They compared the results from the biopsies and the operation for each woman, to see how accurate the two types of biopsy were. 
 
Of the 40 women who had a core needle biopsy:
  • 33 women had the same results from the biopsy and the operation 
  • 4 women had different results from the biopsy and the operation 
  • 1 woman didn’t have surgery 
  • 1 woman had surgery elsewhere and the results were not available
  • 1 biopsy sample wasn’t big enough test
Of the 40 women who had a vacuum assisted biopsy:
  • 28 women had the same results from the biopsy and the operation
  • 4 women had different results from the biopsy and the operation
  • 2 women didn’t have surgery
  • 6 biopsy samples weren’t big enough to test 

The research team asked the women taking part if they would, in theory, be prepared to have a biopsy in the same way again:
  • 38 out of 39 women (97%) who had CNB said yes
  • 33 out of 39 women (85%) who had VAB said yes

The number is a bit higher for CNB but the difference between the groups could be due to chance. It’s difficult to draw any firm conclusions about this because of the small number of people in each group.
 
Pain
The research team asked the women taking part to rate their pain on a scale of 0 (no pain) to 10 (worst pain they could imagine). They did this just after the biopsy, and again at their clinic appointment a week or so later. 
 
The research team looked at the ‘median’ pain score. They work this out by putting the pain scores from all the women in numerical order. The median score is the number in the middle number in that list.
 
The median score for pain just after the biopsy was 1 for women in both groups. 
 
The median score for pain at the clinic appointment was 1 for those who had CNB, and 2 for those who had VAB. 
 
Other side effects
Very few women taking part had side effects other than pain. Two women who had VAB had some bleeding under the skin (a haematoma) after the biopsy. One was taking aspirin, which thins the blood. 
 
The study team recommend that people who take medication to thin their blood shouldn’t have a vacuum assisted biopsy.
 
Conclusion
The study team concluded that a vacuum assisted biopsy is an acceptable test that women would be willing to have. VAB did cause a bit more pain than CNB, but the accuracy for diagnosing cancer was similar. But these results don’t provide enough evidence for the team to recommend that women have a VAB instead of a CNB.
 
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Anthony Maxwell

Supported by

British Society of Breast Radiology (BSBR)
NIHR Clinical Research Network: Cancer
Manchester University NHS Foundation Trust

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

11126

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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