Safety and efficacy of Fully-covered WallFlex stent in patients with distal malignant biliary obstruction: a prospective multicenter study

Safety and efficacy of Fully-covered WallFlex stent in patients with distal malignant biliary obstruction: a prospective multicenter study - WATCH-2 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007131

Enrollment

140

Registered

2012-01-24

Start date

2011-09-01

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

Fully-covered WallFlex stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable distal malignant biliary obstruction, not limited to primary disease. 2) Patients with predictable prognosis of more than 2 months. 3) Patients with written informed consent. 4) Patients with performance status 0-2.

Exclusion criteria

Exclusion criteria: 1) Patients with massive ascites. 2) Patients with severely impaired organ function. 3) Patients for whom endoscopic biliary drainage is difficult. 4) Patients with duodenal obstruction. 5) Patients considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
Stent patency period	—

Secondary

Measure	Time frame
Time to dysfunction, Stent occlusion rate, Stent-related complication rate, Overall survival	—

Countries

Japan

Contacts

Public ContactHirofumi Kogure

Faculty of Medicine, The University of Tokyo Department of Gastroenterology

03-3815-5411

Outcome results

None listed

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