Predicting Incidental Gallbladder Cancer

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.

Conditions

• Gallbladder Cancer

Sponsors & Collaborators

• University of Plymouth

  collaborator OTHER

• Royal Devon and Exeter NHS Foundation Trust

  collaborator OTHER

• Royal Cornwall Hospitals Trust

  collaborator OTHER

• Torbay and South Devon NHS Foundation Trust

  collaborator OTHER

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• North Bristol NHS Trust

  collaborator OTHER

• Gloucestershire Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospital Plymouth NHS Trust

  lead OTHER

Principal Investigators

• Somaiah Aroori · University Hospitals Plymouth NHS Trust, University of Plymouth

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-02

Primary Completion

2029-09-30

Completion

2029-09-30

Countries

• United Kingdom

Study Locations