A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study

A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study - A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013276

Enrollment

132

Registered

2014-03-08

Start date

2014-03-10

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 stricture (MBS)

Interventions

fully covered self-expandable metallic stent (FCSEMS)-M-intraductal partial covered self-expandable metal stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients with inoperable distal malignant biliary strictures 2) patients with malignant biliary strictur comfirmed histopathologically 3) patients with proximal border of malignant biliary stricture thatis far from hilar at least 2cm away

Exclusion criteria

Exclusion criteria: 1) Coagulopathy (PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3) 2) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)

Design outcomes

Primary

Measure	Time frame
Stent patency	—

Secondary

Measure	Time frame
The rates of technical and clinical success	—

Countries

Asia(except Japan)

Contacts

Public ContactYun Nah Lee

Digestive Disease Center and Research Institute, Department of Internal Medicine, Gastroenterology

yunnah@schmc.ac.kr+82-32-621-5094

Outcome results

None listed

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