Efficacy of a covered self-expandable metal stents for unresectable malignant hilar biliary obstruction

Efficacy of a modified covered self-expandable metal stents for unresectable malignant hilar biliary obstruction

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011513

Enrollment

Registered

2026-01-22

Start date

2025-12-30

Completion date

Unknown

Last updated

2026-01-27

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 : (1) Patients who provided informed consent underwent insertion of fully covered self-expandable metal stents (fcSEMS) using a side-by-side (SBS) technique during endoscopic retrograde

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients aged 19 years or older with unresectable malignant hilar biliary obstruction of Bismuth type II or higher, confirmed by imaging studies such as abdominal computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography–CT (PET-CT), and/or by histopathological or cytological examination. (2) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and an expected survival of at least 3 months. (3) Patients meeting criteria (1) and (2) who require initial biliary stent placement or stent exchange due to stent dysfunction following prior placement of a plastic biliary stent.

Exclusion criteria

Exclusion criteria: (1) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of =3 and an expected survival of less than 3 months. (2) Patients who declined or refused to participate in the study. (3) Patients with uncontrolled coagulation disorders. (4) Patients for whom endoscopic intervention was not feasible.

Design outcomes

Primary

Measure	Time frame
stent migration rate	—

Secondary

Measure	Time frame
stent patency;Stent safety	—

Countries

Korea, Republic of

Contacts

Public ContactTae Hoon Lee

Soon Chun Hyang University Hospital Cheonan

taewoolee9@gmail.com+82-41-570-3662

Outcome results