Viewing Study NCT04671095



Ignite Creation Date: 2024-05-06 @ 3:34 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04671095
Status: COMPLETED
Last Update Posted: 2023-09-05
First Post: 2020-12-10

Brief Title: Single Use ERCP Performance -SURE Study
Sponsor: Nottingham University Hospitals NHS Trust
Organization: Nottingham University Hospitals NHS Trust

Study Overview

Official Title: Prospective Observational Cohort Study To Assess the Performance of Single Use Duodenoscope
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SURE
Brief 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 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
Detailed Description: ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both The indications for ERCP are bile duct stones bile duct strictures sphincter of Oddi manometry with sphincterotomy bile leak pancreatic duct stones and pancreatic duct stricture The intended benefits of the procedure are either to relieve bile duct pancreatic duct obstruction or facilitate bile duct pancreatic duct drainage It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery

Gall stones are made of cholesterol pigment and mixture of cholesterol and pigment The incidence of stones with in the bile-duct varies from 46 to 19The stones are predominantly formed in the gall bladder and are displaced from the gall bladder in to the bile duct via the cystic duct ERCP is an effective and minimally invasive treatment for bile duct stones Treatment of extra- hepatic biliary strictures irrespective of their aetiology is to place a stent across the stricture through ERCP and facilitate biliary drainage

There is emerging data that the incidence of carbapenem resistant enterobacteriae Multidrug-resistant Klebsiella pneumoniae and New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli CRE following exposure to contaminated duodenoscopes ERCP endoscopes The main reason for the outbreaks is due to inadequate reprocessing Cleaning of endoscope post procedure leading to contamination of endoscpes

To minimise the risk of contamination and outbreak of above infections single use disposable duodenoscopes have been brought in to the market The aim of the study is to assess the performance of the single use duodenoscope against the standard reusable duodenoscope and the cost consequences associated with the above

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None