A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12

A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 - A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 (NEWCOMER 12)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007061

Enrollment

Registered

2012-01-13

Start date

2012-01-01

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

unresectable distal biliary malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable distal malignant biliary obstruction 2) Prognosis is expected more than 2 months. 3) Written informed consent is obtained. 4) Performance status is grade 2 or smaller

Exclusion criteria

Exclusion criteria: 1) Patients with massive ascites 2) Patients with serious problem in any other organs 3) Patients whose stricture extends to hilar bile duct 4) Patients with Inaccessible to the duodenal papilla (ex. total gastrectomy) 5) Contraindications of endoscopic procedure 6) Patients with intestinal obstruction in the distal to the ampulla

Design outcomes

Primary

Measure	Time frame
1) Stent occlusion rate and dysfunction rate 2) Stent patency duration 3) Time to dysfunction 4) Overall stent patency rate and function rate	—

Secondary

Measure	Time frame
1) Median survival time 2) Stent-related complication rate	—

Countries

Japan

Contacts

Public ContactTsuyoshi Mukai

Gifu Municipal Hospital Department of Gastroenterology

tsuyomukai@yahoo.co.jp058-251-1101

Outcome results