Status:
UNKNOWN
aScope Single Use ERCP Study- ASSURE Study
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
ERCP
Cholangitis
Eligibility:
All Genders
18-90 years
Brief Summary
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 (St...
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 Odd...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 16 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05225909
Start Date
April 1 2022
End Date
February 16 2024
Last Update
February 7 2022
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, Ng7 2UH