Predicting Incidental Gallbladder Cancer
NCT Number: NCT06531408
Acronym: P-iGBC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gallbladder Cancer
Sponsor: University Hospital Plymouth NHS Trust
Collaborators: University of Plymouth|Royal Devon University Healthcare 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
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2029-09

Summary:
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.

Primary Outcome Measures: Validation of a diagnostic score for incidental gallbladder cancer, Completed study. Development of a diagnostic scoring system with a low negative predictive value for incidental gallbladder cancer in UK adult patients undergoing cholecystectomy for benign indications, including gallstones and their complications (e.g. cholecystitis, pancreatitis, colic) and gallbladder dyskinesia, 5 years
Secondary Outcome Measures: Rate of incidental gallbladder cancer, Incidence of incidental gallbladder cancer in a) feasibility cohort and b) completed study cohort, a) 1 year b) 5 years|Rate of benign histological changes, Incidence of non-cancerous histopathological abnormalities including (non-exhaustive) xanthogranulomatous cholecystitis, gallbladder polyps and dysplasia, in a) feasibility cohort and b) completed study cohort, a) 1 year b) 5 years|Feasibility of conducting large scale multi-centre prospective study, Adequacy of rates of recruitment and data completeness in pilot/feasibility patient cohort, 1 year|Feasibility of developing a diagnostic scoring system for the diagnosis of incidental gallbladder cancer based on pre- and intra-operative factors., Adequacy of granularity of data and correlation with anticipated rates of recruitment in pilot/feasibility patient cohort, 1 year|Qualitative Analysis, Qualitative data analysis will be conducted using a pragmatic methodology to identify themes in the transcripts from patient and professional participant interviews.

Data will be assigned codes and these coded data will be organised into themes aligning to the research questions, in order to triangulate perceptions of the risk of incidental gallbladder cancer in routine cholecystectomy between the participant groups, and to define perceived enablers and barriers to selective histological analysis in adult cholecystectomy., 18 months