The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction.
- Who it may be relevant to
- Registry conditions: Biliary Strictures Caused by Malignant Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Clinical Safety and Performance of an Investigational Multi-Hole™ Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
Overview
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
Detailed description
The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Interventions
- Device Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
Multi-hole anti-migration stent for biliary strictures produced by malignant neoplasms
Primary outcome measures
- Primary Endpoints [Time frame: 6 Month]
Eligibility criteria
Inclusion criteria
- Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and/or radiation) for malignant biliary obstruction
Clinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and/or dark urine)
Biochemical evidence (Tbili > 3mg/dL)
High quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)
≥ 18 years of age
Willing and able to provide informed consent
Exclusion criteria
- Participation in another investigational study within 90 days prior to consent
Intrahepatic metastases that extensively involve both lobes of the liver
Patients with a distal malignant biliary obstruction due to potential resectable disease
Strictures that could not be traversed by the delivery system
Perforation of any duct within the biliary tree
Presence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent
Active viral hepatitis
Life expectancy of < 3 months
Patient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
Unwilling or unable to comply with the follow-up schedule
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07715240 · 2025-GI-01