NIPH Clinical Trials Search

Temporary Placement of HANAROSTENT Biliary Multi-Hole Benefit for Benign Biliary Strictures

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Benign Biliary Stricture
Date of first enrollment	25/05/2026
Target sample size	15
Countries of recruitment
Study type	Interventional
Intervention(s)	Study participants will undergo endoscopic retrograde cholangiography (ERCP) for the placement of a single HANAROSTENT Biliary Multi-Hole Benefit (a fully covered self-expandable metallic stent with a multi-hole structure) at the site of the benign biliary stricture. The stent is scheduled for elective endoscopic removal between 60 and 90 days post-placement. Following removal, patients will be monitored through regular outpatient visits with blood tests and imaging to evaluate the maintenance of stricture resolution and long-term safety.

Outcome(s)

Primary Outcome

Rate of freedom from re-stenosis at 12 months after stent removal

Secondary Outcome

1) Technical success rate of stent placement 2) Rate of recurrent biliary obstruction (RBO) 3) Technical success rate of stent removal 4) Rate of stricture resolution 5) Stent-demanding time 6) Short-term clinical success rate (30 days after removal) 7) Rate of freedom from re-stenosis at 6 months after stent removal 8) Time to biliary re-stenosis 9) Rate of spontaneous stent migration 10) Incidence of adverse events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Refractory benign biliary strictures requiring re-treatment despite having undergone at least one endoscopic treatment session using plastic stents. 2) Patients in whom malignant biliary stricture has been ruled out based on imaging findings (e.g., contrast-enhanced CT, MRCP, ERCP), pathological diagnosis, and clinical course. 3) Patients aged 18 years or older at the time of providing informed consent. 4) Patients who are able to comply with the study schedule, including hospital visits and follow-up evaluations. 5) Patients who have provided written informed consent of their own free will after receiving a full explanation and demonstrating a complete understanding of the study.
Exclude criteria	1) Patients with multiple non-contiguous biliary strictures. 2) Patients with a history of metallic stent placement for the target benign biliary stricture. 3) Patients diagnosed with intrahepatic stones based on imaging such as CT, MRCP, or ERCP. 4) Patients categorized as having severe acute cholangitis at the time of informed consent, according to the Tokyo Guidelines 2018 diagnostic criteria and severity grading. 5) Patients with a bleeding tendency confirmed by blood tests within 4 weeks prior to enrollment. 6) Patients for whom preoperative discontinuation or substitution of antithrombotic agents is difficult, according to the Japan Gastroenterological Endoscopy Society guidelines. 7) Patients who are pregnant, breastfeeding, or may become pregnant during the study period. 8) Patients with a history of hypersensitivity to the materials used in the study device. 9) Patients for whom safe placement of the study device is judged to be difficult, such as placement into extremely narrow intrahepatic bile ducts. 10) Patients judged by the principal investigator or sub-investigator to be inappropriate for participation in this study from a medical or ethical perspective.