Single Use ERCP Performance -SURE Study

NCT04671095 | Completed DMC FDA Device

• 1 other identifier: 20GA082
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

ERCP; Infection; Cholangitis

Keywords

EXALT; Single use duodenoscope; ERCP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of complications

  30 days post procedure

• EQ-5D-5L quality of life questionnaire

  30 days

• Endoscopy metrics associated with the procedure

  During the procedure

Interventions

ERCP procedure with single use duodenoscope DEVICE

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

Also known as: ERCP procedure with Single use disposable duodenoscope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Infections; Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Suresh Vasan Venkatachalapathy, MRCP

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: March 9, 2021
• Primary Completion: May 31, 2023
• Study Completion: August 9, 2023
• Last Updated: September 5, 2023

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)