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Single Use ERCP Performance -SURE Study

NCT04671095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Suresh Vasan Venkatachalapathy, MRCP · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2023-05-31
Completion
2023-08-09
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671095 on ClinicalTrials.gov