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A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction

A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction - WATCH study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002293
Enrollment
80
Registered
2009-08-08
Start date
2009-06-01
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

Covered WallFlex biliary stent

Sponsors

Faculty of Medicine, University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: :Unresectable extrahepatic malignant biliary obstruction :Not limited by primary disease, age, and sex :Patients with written informed consent

Exclusion criteria

Exclusion criteria: :Patients for whom endoscopic biliary drainage is difficult. :Patients with hilar malignant biliary obstruction :Patients with duodenal obstruction :Patients with massive ascites :Patients with performance status>=3 :Patients with severely impaired organ function :Patients without written informed consent :Patients considered ineligible for this study.

Design outcomes

Primary

MeasureTime frame
Stent patency period

Secondary

MeasureTime frame
Stent occlusion rate, Stent-related complication rate, Event free survival, overall survival, success rate of stent removal

Countries

Japan

Contacts

Public ContactYousuke Nakai

Faculty of Medicine, University of Tokyo Department of Gastroenterology

03-3815-5411

Outcome results

None listed

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