Single Use ERCP- SURE study
Research type
Research Study
Full title
Multi-centre Prospective observational cohort study: To assess the performance of single use duodenoscope
IRAS ID
291857
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, 0 days
Research summary
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).\n\nThere 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 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.
Summary of Results
ERCP is an endoscopic camera test to remove stones and relieve obstruction from the bile duct (Pipe that connects Liver and small bowel). The risk of infection following ERCP can be as high as one in ten. The disposable endoscopes are sterile and may minimise the risk of infection. We conducted a study involving 4 different large hospitals to assess the function of the endoscope.
Methods:
A multicentre, prospective, observational, cohort study was undertaken to assess the clinical effectiveness and utility of disposable endoscopes in four centres across the UK and Republic of Ireland - Nottingham University Hospitals NHS Trust, Cambridge University Hopsitals NHS Foundation trust, Newcastle upon Tyne Hospitals NHS Foundation Trust and Beaumont Hospital, Dublin.
Primary aim:
To assess the technical success (ability to complete the intended ERCP procedure) of single use duodenoscope.
Secondary aim:
To assess Endoscopy metrics (Time to complete procedure, ease of intubation, ease of intubating duodenum, number of attempts to cannulate CBD, image quality), Patient discomfort during procedure ( collected by nurse independent of study), Complications, Qualitative assessment of the duodenoscope (Questionnaire), Quality of life following procedure, Cost consequence to the NHS.
Results:
Fifty-nine patients were recruited (figure 2 Consort diagram). Thirty-one (52.5%) patients were female. The median age was 64 years. Thirty-three (56%) patients had common bile duct stones and 26 (44%) patients had bile duct strictures. Forty-one patients (62.5%) had the procedure under conscious sedation and 24 (38.5%) had under general anaesthesia.
The procedure was technically successful in 55(93%) of patients and in three patients they had to use a conventional duodenoscope to complete the procedure. One patient had obstruction in the first part of duodenum which precluded from proceeding further. Fifty- four (91%) Patients were either comfortable or experienced mild discomfort in the room and 59 (99%) in recovery. The risk of infection was 10% following the procedure. Patients’ quality of life measure increased progressively over the follow-up days. However, patients with bile duct stone indication and males reported significantly better health states than patients with bile duct stricture indication or females. Allowing for crossover to reusable scope rate of 5% and up to 10% in treatment costs, EXALT single-used duodenoscopes would have to be priced much lower by approx. 80% to break-even on cost.
Conclusion:
This study showed that the disposable endoscope has a good technical success rate of 93%. This is similar to the conventional endoscope that is already in practice. I was associated with improvement in quality of life following the procedure but needs to be reduced in price for it to be cost-effective for NHS.REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0007
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion