A study comparing 2 needles doctors use to take a sample of pancreatic tissue (The SharkBITE study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Other

A swelling in the pancreas could be cancer. To find out if it is cancer doctors take a small piece of tissue (biopsy) from the lump. They use a special type of needle to take the sample.

More about this trial

Doctors use an endoscopic ultrasound to diagnose pancreatic cancer. This combines an endoscopy with an ultrasound. 

A long flexible tube (the endoscope) is put in your mouth and goes down into your stomach. It has a camera on the end to look at the inside of your body. An ultrasound is attached to the tube and this uses sound waves to get a picture of the inside of your body. 

During the endoscopic ultrasound your doctor might take a sample of tissue (biopsy) using the special type of needle. 

There is a new type of needle that they can use to take these tissue samples. Researchers think this needle might be better than the one they are using at the moment. They hope it could improve the accuracy of the diagnosis. 

To find out if it is they want to compare these 2 needles and the samples they take. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if all of the following apply. You:
  • had an ultrasound scan or CT scan that shows there is a lump on your pancreas
  • are having an endoscopic ultrasound of the pancreas 
  • are at least 18 years old 
Who can’t take part
 
You cannot join this study if any of these apply: 
  • more than half of the lump in your pancreas are cysts
  • there is a reason why you aren’t able to have a sample of tissue (biopsy) done, for example you are taking medication that thins your blood such as warfarin 

Trial design

The team need 108 people to take part.

A doctor will do the endoscopic ultrasound. They will take 3 biopsies using each needle. That is a total of 6 biopsies. 

Hospital visits

You have the endoscopic ultrasound in the outpatients department. 

You shouldn’t eat or drink from midnight before the endoscopic ultrasound. You might be able to sip water to about 2 hours before your appointment. 

After your endoscopic ultrasound you should be able to go home the same day if you are feeling well. 

A member of the research team will phone you 7 days after the test to see if you have had any problems.  

Side effects

Endoscopic ultrasound is a very safe procedure and complications aren’t very common. Possible complications can include:
  • a tear in the gullet or small bowel
  • inflammation of the pancreas (pancreatitis) 
We have more information about having an endoscopic ultrasound.

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 Kofi Oppong

Supported by

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Medtronic

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14896

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

Last reviewed:

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