Single Use ERCP Performance -SURE Study

Infection Clinical Trial

— SURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671095
• Other study ID #: 20GA082
• Status: Completed
• Start date: March 9, 2021
• Est. completion date: August 9, 2023

Study information

• Verified date: December 2020
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cholangitis
• ERCP
• Infection

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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