Not Yet RecruitingNot Applicable

Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)

Brazil84 participantsStarted 2026-06-15

Plain-language summary

Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow. There are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection. Currently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking. The purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.

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.
. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.
. Total bilirubin \> 3 mg/dL.
. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.
. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:
.1 Estimated future liver remnant \<40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.

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 comparing two different ways of placing a metal stent to drain a blocked bile duct near the liver — one approach goes above the papilla and one goes through it — can you explain what that difference means for someone in my situation, and which approach you'd normally use for my type of blockage?
2The trial is tracking serious complications like cholangitis, pancreatitis, and bile leaks as its main safety outcomes — given that these are the things being actively studied, what does that tell us about how much is already known about the risks of each drainage method, and how would you weigh that uncertainty against my current condition?
3Since this trial isn't recruiting yet, is there a standard treatment approach you'd recommend right now for my hilar biliary obstruction, and would it make sense to revisit this trial as an option once it opens?
4My diagnosis involves a blockage at the point where the bile duct meets the liver — can you help me understand whether my specific tumor location and stage would even make me a reasonable candidate to discuss for a trial like this when it does open?
5If I were eventually to consider this trial, how many procedures or follow-up visits would likely be involved, and is this the kind of study where I'd still be receiving active treatment for my cancer or mainly being monitored for how well the drainage procedure works?

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.