Multicenter prospective study of a fully covered self-expandable antireflux metal stent for unresectable malignant distal biliary obstruction

Multicenter prospective study of a fully covered self-expandable antireflux metal stent for unresectable malignant distal biliary obstruction - Multicenter prospective study of a fully covered self-expandable antireflux metal stent for malignant distal biliary obstruction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050262

Enrollment

Registered

2023-02-07

Start date

2023-02-07

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 distal biliary obstruction

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable malignant distal biliary obstruction 2) Patients with biliary stricture more than 2cm away from the bifurcation of hepatic ducts 3) Patients with written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with difficult endoscopic intervention 2) Patients with insertion of multiple biliary stents 3) Patients with performance status 4) Patients with severe organ dysfunction 5) Pregnant patients 6) Patients considered ineligible for this study

Design outcomes

Primary

Measure	Time frame
Time to recurrent biliary obstruction (TRBO)	—

Secondary

Measure	Time frame
1) Technical success rate 2) Clinical success rate 3) Complication rate 4) Prognosis 5) Prognostic factor for TRBO	—

Countries

Japan

Contacts

Public ContactNao Fujimori

Kyushu University Hospital Department of Medicine and Bioregulatory Science

fujimori.nao.239@m.kyushu-u.ac.jp092-642-5285

Outcome results