aScope Single Use ERCP Study- ASSURE Study (ASSURE)

Multi-centre Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope (aScope)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholangitis; Infection; ERCP
• Intervention / Treatment: Device: Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope

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 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.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Suresh V Venkatachalapathy, MRCP; Phone Number: 80441 0115 9249924; Email: suresh.venkatachalapathy@nuh.nhs.uk
• Study Contact Backup: Name: Martin W James, PhD, FRCP; Phone Number: 80441 0115 9249924; Email: martin.james@nuh.nhs.net

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who Undergo ERCP procedure with aScope; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60-120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications	Complications associated with the procedure such as bleeding, pancreatitis, post-ERCP infection and perforation	30 days post procedure
Endoscopy metrics	Endoscopy metric will be assessed through a agreed, structured questionnaire	15 minutes after the procedure
Quality of life following the procedure	Quality of life will me measured using validated questionnaire	5 minutes on day 7 and 30

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Study Chair: Suresh V Venkatachalapathy, MRCP, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): January 15, 2024
• Study Completion (Anticipated): February 16, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: aScope; Ambu Ltd
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis
• Other Study ID Numbers: 21GA088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: National research ethics committee does not allow sharing individual participant data because of confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No