The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study

The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study - YABUSAME study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046702

Enrollment

Registered

2022-01-24

Start date

2021-11-18

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

unresectable malignant hilar biliary obstruction

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with unresectable malignant hilar biliary obstruction who are judgeded the necessity of biliary drainage and planned to be placed YABUSAME. Patients who are planned exchange the placed stent to YABUSAME. P.S. (ECOG): 0, 1, 2 Age: 18 years or older Written consent for participation in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: Patients with unremovable SEMS at hilar portion who are planned additionally to be placed YABUSAME. Patients who are planned to be placed YABUSAME via the EUS interventinal route. Patients who do not have hilar obstruction.

Design outcomes

Primary

Measure	Time frame
the non-recurrence rate of biliary obstruction at 6 months	—

Secondary

Measure	Time frame
technical success rate clinical success rate the non-recurrence rate of biliary obstruction at 3 months and 12 months time to recurrence of biliary obstruction overall survival time adverse event	—

Countries

Japan

Contacts

Public ContactKotaro Takeshita

Natioinal cancer center hospital department of hepatobiliary and pancreatic oncology

ktakeshi@ncc.go.jp03-3542-2511

Outcome results