NCT06531408Active, not recruiting
Predicting Incidental Gallbladder Cancer
Identification of Predictive Factors of Incidentally Detected Gallbladder Cancer and Prospective Validation of a Scoring System to Allow Selective Histological Analysis of the Gallbladder
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30000 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 2 Oct 2024
- Primary completion date
- Sept 2029
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06531408
What you commit to
- Study type: Observational
- Planned participants: 30000
- From 2 Oct 2024 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Participants may not enter the study if ANY of the following apply:
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.