A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction

A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction - A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003568

Enrollment

Registered

2010-05-10

Start date

2010-02-01

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

Malignant biliary obstruction

Interventions

Anti-Reflux stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unresectable extrahepatic malignant biliary obstruction Patients who were admitted by cholangitis caused by CMS occulusion due to duodeno-biliary reflux or sludge Not limited by primary disease and male more than 20 years old Patients with written informed consent

Exclusion criteria

Exclusion criteria: Patients for whom endoscopic biliary drainage is impossible Patients with hilar malignant biliary obstruction Patients with performance status 4 Patients with severe impairment of other organ Patients without written informed consent Patients considered ineligible for this study Patients with obstruction of distal side from third portion of duodenum Patients with tumor invasion to the cystic duct Patients with massive ascites

Design outcomes

Primary

Measure	Time frame
Stent patency period Stent occulusion rate	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactHiroyuki Isayama

Graduate School of Medicine and Faculty of Medicine, the university of Tokyo Department of Gastroenterology

isayama-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026