Clinical trial · Observational
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
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Quantitative Cohort
- description
- UK Adult patients (\>=18) undergoing routine cholecystectomy for benign indications, including gallstone disease and gallbladder dyskinesia. Feasibility phase will include up to 500 adult patients. Full phase is anticipated to require up to 30,000 patients, however power will be confirmed after feasibility.
- label
- Qualitative cohort
- description
- UK Adult participants who are either 1. Patients with a history of gallbladder disease, either pre- or post cholecystectomy 2. Surgeons who undertake routine cholecystectomy 3. Healthcare professionals involved in the management or decision making of patients on biliary pathways
Primary outcomes (1)
- measure
- Validation of a diagnostic score for incidental gallbladder cancer
- timeFrame
- 5 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available