Predicting Incidental Gallbladder Cancer

NCT06531408 | Active Not Recruiting

• 1 other identifier: 23/SUR/879
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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 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

Keywords

Incidental Gallbladder Cancer; Diagnostic Modelling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of incidental gallbladder cancer

  a) 1 year b) 5 years

• Rate of benign histological changes

  a) 1 year b) 5 years

• Feasibility of conducting large scale multi-centre prospective study

  1 year

• Feasibility of developing a diagnostic scoring system for the diagnosis of incidental gallbladder cancer based on pre- and intra-operative factors.

  1 year

• Qualitative Analysis

  18 months

Study Arms (2)

Quantitative Cohort

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.

Qualitative cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cholecystectomy for benign gallbladder diseases (most often gallstone disease), who do not have a risk of gallbladder cancer which is significantly higher than the typical patient.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• University of Plymouth: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• Royal Cornwall Hospitals Trust: collaborator
• Torbay and South Devon NHS Foundation Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• North Bristol NHS Trust: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Somaiah Aroori

  University Hospitals Plymouth NHS Trust, University of Plymouth

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: August 1, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

GB (1)