Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis (NCT04840537) | Clinical Trial Compass
UnknownNot Applicable
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
France150 participantsStarted 2018-12-26
Plain-language summary
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.
The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.
The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Who can participate
Age range
18 Years – 85 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:
* Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
* Presence of clinical jaundice and / or biological cholestasis (GGT\> 3N)
* Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
* Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
* No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
* Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
* Patients aged 18 to 85
* Patient who gave his consent to participate in the study
* No contraindication to anesthesia (ASA 1, 2,3)
* Patient affiliated to a social security scheme (beneficiary or beneficiary)
* Absence of pregnancy and current contraception in women of childbearing age
Exclusion Criteria:
* Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
* Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
* History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
* Presence of a plastic or metal biliary pros…
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
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).