Benign Biliary Stricture
Conditions
Interventions
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
Sponsors
Tsuchiya kichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of freedom from re-stenosis at 12 months after stent removal | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYuya Hagiwara
University of Tsukuba Hospital
Outcome results
None listed