ASSURE study
Research type
Research Study
Full title
Multi-centre Prospective observational cohort study: To assess the performance of single use duodenoscope (aScope)
IRAS ID
300243
Contact name
Suresh Vasan Venkatachalapathy
Contact email
Sponsor organisation
Nottingham University hospitals NHS trust.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We do ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as bile duct
stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS).There are some reports that some of the infection may be contributed by contamination of bacteria in the scope.This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. The new single use duodenoscope has been introduced to minimise the risk of post ERCP infection. It is CE marked but limited information about the performance of the above scope (aScope). We want to assess the scope at our hospital. In addition, we also want to assess the cost consequence to the NHS for using the above scope. Hence we want to assess the performance of the scope in the high risk groups for infection.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0100
Date of REC Opinion
9 May 2022
REC opinion
Further Information Favourable Opinion