A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)

A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207) - Comparative study of biliary stent (JIVROSG-0207)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000043

Enrollment

Registered

2005-08-06

Start date

2003-02-01

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 common bile duct obstruction

Interventions

Percutaneous endprosthesis using bare stents. Percutaneous endprosthesis using covered stents.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Malignant and inoperable common bile duct obstruction. 2) Endoprosthesis completed by a tube. 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4) Serum bilirubin level not more than 5.0mg/dl. 5) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 6) Expected survival more than 4 weeks. 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Post choledocho-intestinal anatomosis, hepatocellular carcinoma, duodenal cancer, peritoneal carcinomatosis, mucin-producing tumor. 2) Duodenal or intestinal obstruction. 3) Biliary infection. 4) Pregnancy.

Design outcomes

Primary

Measure	Time frame
Patency of bile duct at 24 weeks after stent placement.	—

Secondary

Measure	Time frame
Technical success rate of tube removal and adverse events	—

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

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