A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction

A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction - A multicenter randomized controlled trial of metallic stent for unresectable distal malignant biliary obstruction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008587

Enrollment

200

Registered

2012-09-01

Start date

2012-11-01

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

WallFlex Fully-covered biliary stent WallFlex Uncovered biliary 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 4 months. 3) Patients with written informed consent. 4) Patients with performance status 0-3.

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 whose antithrombotic drugs cannot be stopped. 6) Patients considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
Time to stent dysfunction	—

Secondary

Measure	Time frame
Effectiveness 1) Stent patency period 2) Survival period 3) Event free survival 4) Stent patency period after reintervention 5) Time to stent dysfunction after reintervention 6) Cost effectiveness Safety 1) Early complications 2) Late complications 3) Technical success rate 4) Removability of the stent 5) Removability of the second stent	—

Countries

Japan

Contacts

Public ContactAkira Kurita

Faculty of Medicine, Kyoto University Department of Gastroenterology and Hepatology

akurita@kuhp.kyoto-u.ac.jp075-751-4319

Outcome results

None listed

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

A multicenter, prospective, randomised study of &quot;covered&quot; versus &quot;uncovered&quot; stents for the management of distal malignant biliary obstruction