Infection Clinical Trial
— SUREOfficial title:
Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope
NCT number | NCT04671095 |
Other study ID # | 20GA082 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 9, 2021 |
Est. completion date | August 9, 2023 |
Verified date | December 2020 |
Source | Nottingham University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 9, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - • Patients who are at high risk of post ERCP infection such as - Jaundice (Bilirubin >21) - Primary sclerosing cholangitis - Post liver transplant anastomotic stricture - Inpatients - Combined procedures (Ex: ERCP+ spy glass cholangioscopy) - Previous inadequate biliary drainage. - Biliary stricture - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. - Grade 1-3 ERCP on complexity grading (ASGE grading) - Able (in the Investigators opinion) and willing to comply with all study requirements. - Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria: - Patients with CBD stones and no jaundice - Sphincter of Oddi manometry. - Female participants who is pregnant, lactating or planning pregnancy during the course of the study. - Patients who are unable to consent for the study. - ERCP for Pancreatic pathology. - Grade 4 complex ERCP (ASGE grading) - Participant who is terminally ill /ECOG 4 - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | completion of the intended ERCP procedure with single use duodenoscope. | To assess if the intended ERCP prcodure can be successfully completed with single use disposable duodenoscope. | 60-120 minutes | |
Secondary | Rate of complications | Complications associated with the procedure such as bleeding, pancreatitis, post-ERCP infection and perforation | 30 days post procedure | |
Secondary | EQ-5D-5L quality of life questionnaire | Quality of life of patients following procedure (EQ-5D-5L questionnaire) This is a descriptive system comprises the following five dimensions, each describ- ing a different aspect of health:mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels: 1=no problem, 2=moderate problem, 3=severe problem | 30 days | |
Secondary | Endoscopy metrics associated with the procedure | 1. Time to complete procedure, ease of intubation, ease of intubating duodenum, number of attempts to cannulate CBD | During the procedure |
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