WithdrawnNot Applicable

Fluorescent Cholangiography and Bile Duct Stones

Stopped: No funding

Denmark0Started 2019-03-25

Plain-language summary

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection. Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order. Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

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 * Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions) * Patient age ≥ 18 years * Preoperative MRCP * Operation performed by a project surgeon Exclusion criteria * Open cholecystectomy (including conversion from laparoscopic to open) * Acute cholecytitis or cholangitis * Pancreatitis * Iodine or indocyanine green allergy * Liver or renal insufficiency * Thyrotoxicosis * Cholecystectomy not the primary surgical procedure * Pregnancy or lactation * Legally incompetent for any reason * Withdrawal of inclusion consent at any time

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

Sensitivity and specificity

Timeframe: 120mins

Trial details

NCT IDNCT03530241

SponsorHvidovre University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-31

View on ClinicalTrials.gov More Gall Stones, Common Bile Duct trials