P-iGBC, or Predicting Incidental Gallbladder Cancer, is the short title of this study. The study aims to develop a scoring system which surgeons could use to work out whether a patient who is have routine gallbladder surgery has a high or a low risk of gallbladder cancer.

 

Gallbladder cancer is very rare and can be difficult to diagnose, especially in its early stages. This means that up to half of these cancers are diagnosed unexpectedly post-op in laboratories. When this happens, it is called “incidental” gallbladder cancer. Incidental cancer is found in around 1 in every 500 patients who have their gallbladder removed routinely.

 

At the moment, most surgeons check for incidental cancer by sending every removed gallbladder to the laboratory, however this means testing over 70,000 gallbladders at a cost of over £5,000,000 each year in England alone.  This also puts lots of extra pressure on laboratories, who are nationally short-staffed.

 

Some researchers think that we could be more selective and only send high risk gallbladders to reduce these pressures. To do this, we first need a good way to identify which gallbladders are high risk. If we knew what an individual patient’s risk was, we may also be able to prioritise care for the most high-risk patients.

 

To do that, we need to collect information from lots of patients having their gallbladders removed – and you might be one of those patients! We don’t need to change your care in any way, only to “observe” you. We will collect information about you in a secure way which means that you cannot be identified by anyone outside of your normal care team. The information will include things like your age, your medical problems, the results of your tests and what happens during your operation. We will also collect the result of the test on your gallbladder form the laboratory. When enough information has been collected, we will be able to use statistical tests to work out which factors make someone have a higher risk of incidental cancer. When we know these risk factors, we will try to develop the scoring system.

 

We won’t ask patients’ permission to collect the data, because we won’t be changing their care, nor will we be asking for anything which isn’t normally recorded. We have asked patients whether they feel this is acceptable, and they have agreed that it is, however we all agree that patients do not have to take part and should be able to opt-out if they are concerned. You can do this by speaking to your surgeons, or by contacting your local study team.

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For further information, including how information about you will be used, please read the participant information sheet. You can find the most up-to-date version on the Study Documents page.