Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction

Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction - Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060060

Enrollment

Registered

2025-12-29

Start date

2026-01-01

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 who underwent the first biliary drainage with a permanent stent for unresectable malignant hilar biliary obstruction classified as Bismuth type I-III

Exclusion criteria

Exclusion criteria: 1) Patients who had undergone upper gastrointestinal reconstruction other than Billroth I 2) Patients after bilioenteric anastomosis 3) Patients in whom clinical success is not expected by stent placement 4) Patients with temporary biliary drainage 5) Patients with transpapillary biliary stent placement and biliary-enteric anastomosis 6) Patients undergoing tumor ablation for biliary stricture 7) Patients with history or presence of benign biliary stricture 8) Pregnant patients

Design outcomes

Primary

Measure	Time frame
time to recurrent biliary obstruction	—

Secondary

Measure	Time frame
Causes of recurrence of biliary obstruction (RBO) Technical success rate Clinical success rate Rate of early adverse events Rate of late adverse events other than RBO Survival period Feasibility and success rate of reintervention in case of RBO	—

Countries

Japan

Contacts

Public ContactToji Murabayashi

Ise Red Cross Hospital Department of Gastroenterology

murabayashitoji@m2.gmobb.jp0596-28-2171

Outcome results