Active not recruitingOBSERVATIONAL

Predicting Incidental Gallbladder Cancer

This research study is looking at adult patients in the UK who are having their gallbladder removed, typically for common problems like gallstones. Sometimes, a very rare and unexpected gallbladder cancer is found after surgery. The main aim of this study is to discover warning signs that could help doctors predict when this might happen. Researchers will collect information about patients, their tests, and what happens during surgery to create a scoring system. This system would help doctors decide which removed gallbladders need a closer look in the lab. This could make sure that only gallbladders with a higher chance of cancer are sent for these detailed tests, potentially making the process more efficient and avoiding unnecessary stress for patients.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Plymouth NHS Trust

Enrolment target

30,000

Start

02 Oct 2024

Estimated completion

01 Sep 2029

Gallbladder Cancer

What is this study about?

Imagine you're having your gallbladder removed, which is a common operation. Most of the time, everything goes smoothly, and the gallbladder is removed because of gallstones or infection. However, very, very rarely, a tiny cancer might be found in the gallbladder afterwards, even though no one expected it before the operation.

This study is trying to understand if there are certain things about a person, their test results, or their surgery that could give doctors a clue when this unexpected cancer might be present. The goal is to build a special scoring system based on these clues. This score would help doctors decide whether a removed gallbladder needs a detailed check in the lab to look for cancer, or if it's very unlikely to have this unexpected cancer and doesn't need those detailed checks. This could help make sure that patients who might have a higher risk get the right checks, while avoiding extra worry and unnecessary tests for those who don't.

To do this, researchers will gather information from many adults across the UK who are having gallbladder surgery. They'll look at things like medical history, test results before surgery, and what the doctor sees during the operation. They'll be careful to collect this information in a consistent way, which is important for making sure the new scoring system is reliable and works well for patients in the UK. They also want to talk to people about how they feel about giving gallbladders extra checks only if they have certain risk factors.

Key takeaways

Study aims to predict unexpected gallbladder cancer during routine surgery.
No changes to your planned surgery or medical care.
Information from your routine care will be used to create a scoring system.
Could help improve detection for future patients.
Participation is voluntary and won't affect your treatment.

Who may be eligible?

This study is for adults aged 18 or over who are having their gallbladder removed because of common problems like gallstones (including when they cause problems like pancreatitis) or a condition called biliary dyskinesia, which affects how the gallbladder squeezes.

However, you won't be able to join the study if there are already signs or suspicions of gallbladder or bile duct cancer before your surgery. This also includes if scans show specific problems with your bile ducts (like type III/IV Mirizzi syndrome or choledochal cysts), if you've been diagnosed with certain liver conditions like Primary Sclerosing Cholangitis, or if you have gallbladder polyps that are 5mm or larger. You also can't join if your gallbladder is being removed as part of a different main operation.

Quick self-check

Are you 18 years old or older?
Are you having your gallbladder removed for gallstones or a similar common problem?
Do doctors currently suspect you might have gallbladder cancer?
Do you have certain bile duct problems or large gallbladder polyps?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This is an observational study, which means you won't be asked to do anything new or different as a patient. You will have your routine gallbladder surgery as planned. The researchers will simply collect information about you from your medical records, including details from your tests before surgery and what the surgical team finds during your operation. They will also note the results of any lab tests done on your gallbladder after it's removed. There are no extra visits, assessments, medications, or follow-up appointments required as part of this study itself. The information will be collected by doctors in training during your normal care. The total duration of your involvement is simply the period during and around your gallbladder surgery when this information is gathered.

Potential risks and benefits

There are no direct benefits or risks to you from taking part in this study, as it only involves collecting information from your routine care. Your treatment will not change because of the study. However, the information gathered could help improve care for future patients by developing a better way to identify those at risk of unexpected gallbladder cancer. You are always in control and free to decide not to have your information used in the study at any time, without it affecting your medical care.

Locations (1)

University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom

Common questions

What is 'incidental gallbladder cancer'?

It's a very rare cancer found in the gallbladder after it's been removed, even though doctors didn't expect it before the operation.

Will taking part change my surgery or treatment?

No, taking part in this study will not change your planned surgery or any part of your medical care.

Do I need to do anything extra if I agree to take part?

No, you don't need to do anything extra. The study only involves doctors collecting information from your existing medical records and surgery details.

Why is this study important?

It aims to help doctors better identify patients who might have an unexpected gallbladder cancer, so these special cases can get the right follow-up, potentially improving care for future patients.

Will my personal details be kept private?

Yes, all personal information collected for the study will be handled carefully to protect your privacy and kept confidential.