Predicting Incidental Gallbladder Cancer

Launched by UNIVERSITY HOSPITAL PLYMOUTH NHS TRUST · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to predict the risk of finding unexpected gallbladder cancer in adults who are having surgery to remove their gallbladder, usually due to issues like gallstones or infection. The researchers want to see if they can identify certain risk factors that could help create a scoring system. This system would help doctors determine which patients are at higher risk for gallbladder cancer and might need additional testing during their surgery.

To be eligible for the study, participants must be adults aged 18 and older who are scheduled for gallbladder surgery for non-cancerous reasons, such as symptomatic gallstone disease. However, individuals with certain conditions, like previous gallbladder cancer or significant abnormalities in their bile ducts, will not be included. Participants can expect to have their medical information collected, including details from their surgery. The study will first test its design with a smaller group, and if successful, it aims to gather data from up to 30,000 patients. Additionally, there will be interviews to understand how patients feel about the risks of incidental gallbladder cancer and how a good risk score could influence their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All adult patients (\>=18 years of age) undergoing cholecystectomy (including subtotal and remnant cholecystectomy) for benign indications:
• • Symptomatic Gallstone Disease (includes Gallstone Pancreatitis)
• • Biliary Dyskinesia
• Exclusion Criteria:
• Participants may not enter the study if ANY of the following apply:
• • Imaging suspicious for/confirming type III/IV Mirizzi syndrome.
• • History of gallbladder or biliary tree malignancies
• • Any pre-operative clinical suspicion of Gallbladder or biliary tree malignancy, (even if subsequently dismissed or disproven)
• • Presence of Gallbladder polyps ≥5mm
• • Biliary tree abnormalities, including Primary Sclerosing Cholangitis and Choledochal Cysts
• • Patients undergoing cholecystectomy as a part of, or incidental to, another procedure.