CompletedNot Applicable

Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String

Netherlands40 participantsStarted 2023-03-01

Plain-language summary

Prospective pilot study to assess the feasibility and efficacy of intrahepatic plastic biliary stents with a retrieval string in patients with presumed resectable perihilar cholangiocarcinoma requiring biliary drainage of the future liver remnant.

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: * 18 years or older. * Capable of providing written and oral informed consent. * Presumed perihilar cholangiocarcinoma. * Biliary obstruction in the future liver remnant. * Drainage naïve patients: total bilirubin \>50 umol/L * Patients with previous endobiliary drainage procedures: persistently rising total bilirubin \>50 umol/L (i.e. no stent placed or insufficient draining stent) or persistent biliary dilatation in the future liver remnant on imaging (i.e. previous stent placed in contralateral side of the liver). Exclusion Criteria: * Incompletely recovered from any side effects of previous biliary drainage procedures. Patients are required to be off antibiotic treatment for at least 5 days. * Any contra-indication for major liver surgery (e.g. ECOG/WHO score ≥3). * Technical contra-indications for endobiliary drainage (e.g. previous gastrojejunostomy). * Distance between stricture and sphincter less than 2 cm. * Refusal to provide informed consent.

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

Severe adverse events between inclusion and exploratory laparotomy

Timeframe: Between inclusion and surgery. In patients who will not undergo exploratory laparotomy, the number of drainage-related complications will be measured until 7 days after the decision to cancel exploratory laparotomy or 90 days after inclusion, whichever

Trial details

NCT IDNCT05874934

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-21

View on ClinicalTrials.gov More Perihilar Cholangiocarcinoma trials