A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.

A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction. - A randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000738

Enrollment

112

Registered

2007-06-11

Start date

2007-06-01

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

Distal malignant biliary obstraction

Interventions

Insertion of covered self expandable metal stents Insertion of uncovered self expandable metal stents

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, Patinets who are admitted in the International Medical Center of Japan (IMCJ). 2, Obstraction of the distal bile duct without hilar lesions because of tumor invasion or compression of metastatic lymph nodes. 3, The tumors are unresectable because of tumor progression and/or patient's complications. 4, Performance status (PS) are 0 to 3.

Exclusion criteria

Exclusion criteria: 1, Patients with severe dysfunction of liver, kidney, heart, or lung. 2, Patients who are estimated to die within two months. 3,Patients with history of insertion of biliay metal stents 4, Patients with history of surgery of the common bile ducts. 5, Patients with stenosis of the hepatic ducts or the intra hepatic bile ducts. 6, Patients with stenosis of the duodenum which prevent passage of foods.

Design outcomes

Primary

Measure	Time frame
Comparison of the duration of the stents patency	—

Secondary

Measure	Time frame
comparison of the safty comparison of the cost	—

Countries

Japan

Outcome results

None listed

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