An observational study in ERCP, Cholangitis and Infection, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Nottingham University Hospitals NHS Trust · Observational
Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)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. The investigators do not know what percentage of infection is secondary to the above. The new single use duodenoscope (aScope, Ambu Ltd) has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked but the evidence for performance of the aScope is limited. The investigators want to assess the performance of the scope simultaneously in multiple different hospitals. In addition, the investigators also want to assess the cost consequence to the NHS for using the above scope. Hence, the investigators want to assess the performance of the scope in the high risk groups for infection.
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 extrahepatic 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 endoscopes. To minimize 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 and the cost consequences associated with the above.
82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.
This study's enrollment of 59 is below the median of 250 across 27 observational studies indexed under Cholangitis.
Browse Cholangitis studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.
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The population studied will be patients who need ERCP procedure. All consecutive patients who are referred for ERCP will be screened to see if they meet the eligibility criteria to participate in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who are at high risk of post ERCP infection such as
Exclusion Criteria:
Patients with CBD stones and no jaundice
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This will be patients who undergo ERCP procedure using aScope.
Device: Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope
ERCP Procedure will be done using aScope. We will assess the performance of the aScope.
Completion the intended ERCP procedure with single use duodenoscope.
To assess if the intended ERCP procedure can be successfully completed with single use disposable duodenoscope.
Time frame: 60-120 minutes
Rate of complications
Complications associated with the procedure such as bleeding, pancreatitis, post-ERCP infection and perforation
Time frame: 30 days post procedure
Endoscopy metrics
Endoscopy metric will be assessed through a agreed, structured questionnaire
Time frame: 15 minutes after the procedure
Quality of life following the procedure
Quality of life will me measured using validated questionnaire
Time frame: 5 minutes on day 7 and 30
Plan to share: No — National research ethics committee does not allow sharing individual participant data because of confidentiality
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Jan 2025, 30 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Nottingham University Hospitals NHS Trust →