Archimedes Bio-degradable Bile Duct Stent Study (NCT04477005) | Clinical Trial Compass
CompletedNot Applicable
Archimedes Bio-degradable Bile Duct Stent Study
United Kingdom64 participantsStarted 2020-11-11
Plain-language 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 leaks and patients with bile duct stones and intact gall bladder will be recruited to the study. The planned sample size is 53 and patients will be followed up for 180 days. The primary objective is to assess the utility of biodegradable bile duct plastic stents in the drainage of bile duct.
The secondary Secondary objectives are To assess
1. Technical success of biodegradable stents
2. Complications
3. Patient related cost savings (Time off work, travel time for the patient)
4. Hospital related cost savings (Repeat procedure costs, follow up appointments)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resolution of bile leak
Timeframe: 180 days
2
Incidence of cholangitis in patients who had ERCP for bile duct stones and are awaiting gall bladder removal.