Status:
ACTIVE_NOT_RECRUITING
Predicting Incidental Gallbladder Cancer
Lead Sponsor:
University Hospital Plymouth NHS Trust
Collaborating Sponsors:
University of Plymouth
Royal Devon and Exeter NHS Foundation Trust
Conditions:
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Brief 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 conditio...
Detailed Description
This is a cross-sectional study of prospectively identified (identified in advance) patients undergoing routine gallbladder surgery in the United Kingdom (UK). It will be undertaken in two phases and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
30000 Patients enrolled
Trial Details
Trial ID
NCT06531408
Start Date
October 2 2024
End Date
September 1 2029
Last Update
June 3 2025
Active Locations (1)
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1
University Hospitals Plymouth NHS Trust
Plymouth, Devon, United Kingdom, PL6 8DH