Status:
COMPLETED
Archimedes Bio-degradable Bile Duct Stent Study
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
Bile Leak
Common Bile Duct Stone With Chronic Cholecystitis
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective observational cohort study to assess the utility of bio-degradable bile duct stent in the drainage of bile duct. All consecutive patients who will undergo ERCP procedure for bile...
Detailed Description
This is a Multi-centre prospective observational cohort study assessing biodegradable stents in the drainage of bile duct. The participating organisations are Nottingham university hospitals NHS trust...
Eligibility Criteria
Inclusion
- • Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Patients who have an indication for ERCP.
- Patients who have bile leak either post cholecystectomy or liver resection.
- Patients who are on the waiting list for cholecystectomy for gall stones but have bile duct stones and listed for removal of bile duct stones.
- 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
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Patients who are unable to consent for the study.
- Participant who is terminally ill
- Patients who come for ERCP and routine stent change
- 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 :
November 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04477005
Start Date
November 11 2020
End Date
August 2 2023
Last Update
August 31 2023
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH