NCT04671095

Single Use ERCP Performance -SURE Study

Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 4.6% to 19%.The 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.

Conditions

• ERCP
• Infection
• Cholangitis

Interventions

Type	Name	Description
DEVICE	ERCP procedure with single use duodenoscope	ERCP is an endoscopic procedure done to relieve bile duct obstruction. It is done either under conscious sedation or deep sedation. The endoscope is inserted thorough the mouth and is taken to the second part of duodenum (small bowel). The ampulla is identified and the bile duct is cannulated. Biliary obstruction is relieved either by placing a stent or removing the stone/s

Timeline

• Start date: 2021-03-09
• Primary completion: 2023-05-31
• Completion: 2023-08-09
• First posted: 2020-12-17
• Last updated: 2023-09-05

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study