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A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer

A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer - "Covered" vs "uncovered" metallic stents for biliary stricture by unresectable middle to lower bile duct cancer.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009779
Enrollment
120
Registered
2013-01-14
Start date
2009-03-01
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

Biliary stricture caused by unresectable middle to lower bile duct cancer

Interventions

Covered metallic stent (CMS) Uncovered metallic stent (UMS)

Sponsors

Kansai Endoscopic Device Selection (EDS) Working Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Unresectable middle to lower bile duct cancer. 2) Pathological confirmation is essential. 3) Stricuture is located to middle to lower bile duct. 4) Clinical stage (UICC) is more than stage 2b. 5) Informed consent is essential.

Exclusion criteria

Exclusion criteria: 1) PS>4 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient.

Design outcomes

Primary

MeasureTime frame
duration until stent dysfunction—

Secondary

MeasureTime frame
1) overall survival 2) incedence of side effect—

Countries

Japan

Contacts

Public ContactKiyohito Tanaka

Kyoto Secind Red Cross Hospital Department of Gastroenterology

075-231-5171

Outcome results

None listed

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