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

RecruitingNAAges 18 Years - anyAllHospital de Clinicas de Porto Alegre
NCT07558304 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 eff

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age \>18 years. 2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion. 3. Total bilirubin \> 3 mg/dL. 4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition. 5. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria: 5.1 Estimated future liver remnant \<40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage. 5.2 Prolonged jaundice with total bilirubin \>10 mg/dL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin \<3 g/dL, presumably attributable to cholestasis. 5.4 Indication for neoadjuvant chemotherapy. Exclusion Criteria: 1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage. 2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP). 3. Acute cholangitis, clinically defined as fever (axillary temperature \>38°C) and leukocytosis (white blood cell count \>10,000/mm³). 4. Uncorrectable coagulopathy. 5. Iodinated contrast allergy not amenable to desensitization.
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What it tests

  • Percutaneous transpapillary internal-external biliary drainage
  • Percutaneous suprapapillary biliary drainage with self-expanding metal stent
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Where

2 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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