EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction (NCT05595122) | Clinical Trial Compass
UnknownNot Applicable
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
Netherlands25 participantsStarted 2022-12-02
Plain-language summary
A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.
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:
* Radiographically (CT or EUS) distal malignant bile duct obstruction
* Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices
* Indication for biliary drainage; in case of a resectable tumour this should be discussed during a clinical multidisciplinary meeting
* Written informed consent
Exclusion Criteria:
* Age \< 18 year
* Surgically altered anatomy after previous gastric, periampullary or duodenal resection
* Cancer extending into the antrum or proximal duodenum
* Extensive liver metastases
* WHO performance score of 4 (in bed 100% of time)
* Uncorrectable coagulopathy, defined by INR\>1.5 or platelets \< 50 x 10\^9/L\*
* Clinically relevant gastric-outlet obstruction
* Unable to complete sign informed consent
* Inclusion is allowed after corrective treatment measures are taken, according to local protocol and treating physician.
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.
1This trial is testing EUS-guided choledochoduodenostomy as a first-line drainage option rather than the standard ERCP approach — can you walk me through how those two procedures differ in terms of risks and recovery, and why one might be better suited to my specific situation?
2The trial is specifically looking at how often the stent stops working properly after a technically successful procedure — what does 'stent dysfunction' mean in practice, and what would happen to me if that occurred?
3Since this trial's recruitment status is listed as unknown, is it currently enrolling patients, and if not, are there similar studies or standard-of-care options I should be considering instead?
4My diagnosis involves a distal biliary obstruction related to a pancreatic or bile duct tumor — given where my obstruction is located, am I even a candidate for EUS-guided choledochoduodenostomy, or does my anatomy make one approach safer than the other?
5Because this is listed as phase 'NA' rather than a traditional phase I, II, or III trial, what does that mean for how much is already known about the safety and effectiveness of this procedure, and how should that factor into my decision?
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
Stentdysfunction after technical successful EUS-CDS
Timeframe: 6 months
Trial details
NCT IDNCT05595122
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)