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A prospective study of re-intervention with 12mm diameter biliary metallic stent for recurrent biliary obstruction

A prospective study of re-intervention with 12mm diameter biliary metallic stent for recurrent biliary obstruction - Revision study with 12mm covered self expandable metallic stent

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034043
Enrollment
55
Registered
2018-09-10
Start date
2018-09-10
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

unresectable malignant distal biliary obstruction

Interventions

12mm full-covered type self expandable metallic stent

Sponsors

Center for Gastroenterology, Tein e-Keijinkai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unresectable malignant distal biliary obstruction 2. Prior biliary drainage with full-covered self expandable metallic stent whose diameter is less than 10mm 3. Complication of recurrent biliary obstruction that requires biliary drainage 4. More than 20 years old 5. Less than Grade 3 of performance status 6. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Failure to extract the indwelling stent 2. Failure of biliary intervention after stent extraction 3. More than type 2 in Bismuth classification 4. Severe comorbilidity 5. Patients considered ineligible by attending physicians

Design outcomes

Primary

MeasureTime frame
Time to recurrent biliary obstruction after re-intervention

Secondary

MeasureTime frame
Success rate of stent extraction, technical success rate, clinical success rate, associated factors with recurrent biliary obstruction after re-intervention

Countries

Japan

Contacts

Public ContactKazunari Tanaka

Teine-Keijinkai Hospital Center for Gastroentelogy

kazunari0511@gmail.com011-681-8111

Outcome results

None listed

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