NCT04671095: SURE

Single Use ERCP Performance -SURE Study

Completed Last updated 5 September 2023

What this trial tests

trial testing ERCP procedure with single use duodenoscope in ERCP in 60 participants. Completed in 9 August 2023.

Timeline

9 March 2021

Primary endpoint
31 May 2023

9 August 2023

Quick facts

Lead sponsor	Nottingham University Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	9 March 2021
Primary completion	31 May 2023
Estimated completion	9 August 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• ERCP procedure with single use duodenoscope

Conditions studied

• ERCP — all drugs for ERCP →
• Infection — all drugs for Infection →
• Cholangitis — all drugs for Cholangitis →

Sponsor

Nottingham University Hospitals NHS Trust

Who can join

Adults 18 to 90, any sex, with ERCP or Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. We do not know what percentage of infection is secondary to the above. The new single use duodenoscope has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked and a single centre study reported that the above performance of the above scope was comparable to the standard reusable scope. We want to assess the scope simultaneously in multiple different hospitals. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection - from bench studies to clinical evidence.
   Lisotti A, Fusaroli P, Napoleon B, Cominardi A, et al · · 2022 · PMID 35721249 · DOI 10.5662/wjm.v12.i3.122