P-iGBC: Predicting Incidental Gallbladder Cancer V1
Research type
Research Study
Full title
Identifying predictive factors of incidentally detected gallbladder cancer and prospective validation of a scoring system to allow selective histological analysis of the gallbladder
IRAS ID
334671
Contact name
Somaiah Aroori
Contact email
Sponsor organisation
University Hospitals Plymouth NHS Trust
Duration of Study in the UK
4 years, 0 months, 3 days
Research summary
Across the UK, 70,000 gallbladder removal operations are performed every year for symptomatic gallstones. It is routine practice to send the removed gallbladders for microscopic examination (histology) to ensure that an underlying incidental gallbladder cancer (IGBC) is not missed. Currently, we don’t have a reliable way to check an individual patient’s risk of IGBC, so UK surgeons usually send all removed gallbladders for histology. However, in the UK, the incidence of IGBC is low, around 1:500. To diagnose one cancer, 499 gallbladders are being sent for testing. This puts much strain on histopathology laboratories and costs over £5,000,000 yearly.
We want to develop a scoring system to identify high-risk patients who could receive faster care and help solve this problem by identifying low-risk patients who might not need histopathology at all. To develop this system, we need to collect information from up to 30,000 people who have cholecystectomies. We need basic information about patients, their background health, pre-operative test results, details of operation, and their gallbladder microscopic examination results.
Before such a large-scale multicentre study, we want to conduct a feasibility study to ensure that relevant data is collected correctly to make a future large-scale study worthwhile. Therefore, we will conduct a smaller “feasibility” study first. This will consist of a “pilot” of the main study of 500 patients from 8-10 hospitals. We will also interview patients, surgeons, and other pathologists to understand how they perceive the risk of IGBC and whether they feel that only testing some gallbladders is acceptable. If we show that the main study will be feasible, we will collect information from many hospitals over 2-3 years. We will use this information to develop a scoring system for surgeons. Eventually, this could lead to better prioritisation of patients and save the NHS time and money.
REC name
London - Central Research Ethics Committee
REC reference
24/LO/0504
Date of REC Opinion
6 Aug 2024
REC opinion
Further Information Favourable Opinion