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Safety and efficacy of plastic stents in malignant hilar biliary obstructio

Compartive study of safety and efficacy between newly developed Twist plastic stent and single pigtail plastic stent in Malignant hilar biliary obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010868
Enrollment
108
Registered
2025-08-08
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In patients with malignant hilar biliary obstruction, endoscopic retrograde cholangiopancreatography (ERCP) will be performed, with the planned insertion of Twist biliary stents in pa

Sponsors

Hallym University Medical Center-Dongtan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 19 years or older, both male and female, who have been diagnosed with malignant hilar biliary obstruction based on Computed Tomography, Magnetic Resonance Imaging, Endoscopic Ultrasound, or other imaging studies, and require endoscopic retrograde cholangiopancreatography (ERCP).

Exclusion criteria

Exclusion criteria: *Patients with bleeding disorders or coagulopathy (e.g., DIC), or those with a platelet count below 60,000/mm³ or an INR greater than 1.5 *Patients who cannot postpone anticoagulant therapy *Patients who are hemodynamically unstable (e.g., in shock) *Women of childbearing potential who are unable to use appropriate contraception or who are pregnant *Patients with psychiatric illnesses or conditions that make participation in the clinical trial impossible (e.g., dementia, seizure) *Any other cases in which the investigator deems the Twist biliary stent procedure inappropriate

Design outcomes

Primary

MeasureTime frame
3-months patency rate

Secondary

MeasureTime frame
overall stent patency;Overall survival of patient

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026