Predicting Incidental Gallbladder Cancer

The goal of this observational study is to identify risks factors for incidental (unexpected) gallbladder cancer in adult patients undergoing routine gallbladder surgery (cholecystectomy) for conditions such as gallstones or infection. The main question it aims to answer is: Can the investigators use risk factors for incidental gallbladder cancer to develop a diagnostic score which could be used to stratify the risk of gallbladder cancer in patients undergoing routine cholecystectomy? Participants undergoing gallbladder surgery will be identified by surgical trainees and data will be collected about the patients, their tests and the findings at their operation. The surgical trainees will also collect the result of any laboratory tests on their gallbladder. The study will occur in two stages - the first stage, called a feasibility phase, will test the study design and make sure that it is possible to collect the necessary information. If this stage is a success then information will be collected from as many as 30,000 patients. There will also be an interview-based study running alongside the feasibility phase, which will explore perceptions of the risk of incidental gallbladder cancer in routine gallbladder surgery, and whether - with a good diagnostic score - it could be acceptable to only send high-risk gallbladder's for histopathology.

NCT Number	NCT06531408
Lead Sponsor	University Hospital Plymouth NHS Trust Collaborators: University of Plymouth, Royal Devon and Exeter NHS Foundation Trust, Royal Cornwall Hospitals Trust, Torbay and South Devon NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, North Bristol NHS Trust, Gloucestershire Hospitals NHS Foundation Trust
Conditions	Gallbladder Cancer
Enrollment	30,000 participants
Start Date	2024-10-02
Primary Completion	2029-09 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2025-06-03