Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Duc… (NCT07115420) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent
New Zealand100 participantsStarted 2025-09
Plain-language summary
This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain.
A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked.
To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents:
* A plastic stent (double pigtail stent or DPS)
* A metal stent (fully covered self-expanding metal stent or FCSEMS)
The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work.
The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer
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:
* Age ≥18 years.
* Radiologically or histologically proven malignant distal bile duct obstruction with unresectable or metastatic disease, including those who have already failed ERCP
* Indication for biliary drainage with presence of obstructive jaundice biochemically and dilated biliary system on imaging.
* Informed consent provided.
* Common bile duct (CBD) size of at least 12mm on EUS imaging
Exclusion Criteria:
* Previous biliary stenting or surgery precluding EUS-CDS.
* Inability to provide informed consent.
* Pregnancy.
* Significant coagulopathy that is not correctable.
* Futility of intervention e.g. pre-terminal patients
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
To compare the incidence of stent dysfunction (defined as recurrent jaundice and/or cholangitis) in patients with malignant biliary obstruction receiving FCSEMS vs DPS stent-in-stent through LAMS