A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.

A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer. - "Covered" vs "uncovered" metallic stents for biliary stricture by unresectable pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009778

Enrollment

120

Registered

2013-01-14

Start date

2009-04-01

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 pancreatic cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pancreatic head cancer with biliary stricture 2) Pathological confirmation is essential. 3) Stricture of bile duct is middle to lower common 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

Measure	Time frame
duration until stent dysfunction	—

Secondary

Measure	Time frame
1) overall survival 2) incidence of side effect	—

Countries

Japan

Contacts

Public ContactKiyohito Tanaka

Kyoto Second Red Cross Hospital Department of Gastoroenterology

075-231-5171

Outcome results

None listed

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

A prospective randomized study of &quot;covered&quot; vs &quot;uncovered&quot; metallic stents for the management of biliary stricture by unresectable pancreatic cancer.