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12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction

RecruitingNAAges 19 Years - anyAllChung-Ang University Hospital
NCT07559968 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide eviden

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks * Adults aged 19 years or older * Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation * Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract Exclusion Criteria: * Patients with a previous history of biliary metallic stent placement * Patients with upper biliary obstruction (hilar level or above) * Patients with other major biliary lesions in addition to malignant distal biliary obstruction * Patients for whom the investigator judges that study conduct or data collection would be markedly difficult
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What it tests

  • 12-mm partially covered self-expandable metallic stent
  • 12-mm bare self-expandable metallic stent
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Where

1 site
Chung-Ang university Hospital
Seoul, South Korea
🤝 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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