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A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis.

A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis. - A multicenter prospective study to assess utility and safety of a metal stent

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000021440
Enrollment
80
Registered
2016-03-12
Start date
2016-02-15
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

Obstructive jaundice

Interventions

None listed

Sponsors

Kinki University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patinets with unresectable malignant distal biliary stenosis with histological evidence 2. ECOG(Eastern Cooperative Oncology Group) performance status 0-3 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Inability to expect efficacy of biliary drainage 2. severe failure of the other organs: ASA classification of 3 or more 3. ECOG performance status 4 4. poor prognosis of 3 months or less 5. complication with hilar stenosis due to lymph node metastasis 6. post-surgical reconstruction of bile duct

Design outcomes

Primary

MeasureTime frame
stent patency

Countries

Japan

Contacts

Public ContactKentaro Yamao

Kinki University Faculty of Medicine Department of Gastroenterology and Hepatology

yamaken_volvo@yahoo.co.jp072-366-0221

Outcome results

None listed

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