Suprapapillary Metal Stent vs. Routine Drainage for Malignant Hilar Biliary Obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two percutaneous biliary drainage approaches in adults with malignant proximal hilar obstruction. It examines whether suprapapillary drainage using a self-expanding metal stent provides safer or more effective bile decompression than the conventional transpapillary internal-external catheter. Patients are adults with unresectable or high-risk disease, elevated bilirubin, and radiographically confirmed obstruction. Outcomes of interest include procedure-related safety, rate of infectious complications, and degree of biliary decompression. The trial addresses a clinical decision point where optimal drainage technique remains uncertain.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital de Clínicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital de Clínicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Not yet recruiting

Study contacts

• Study coordinator: Cleber R. P. Kruel, Professor
• Email: crkruel@hcpa.edu.br
• Phone: +55(51)3359-8232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.