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A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma

A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma - NABIS-02 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025584
Enrollment
10
Registered
2017-02-01
Start date
2017-03-15
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

Preoperative perihilar cholangiocarcinoma

Interventions

Exchange the drainage methods from ENBD to Fully covered Metallic Stent

Sponsors

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Operable perihilar cholangiocarcinoma. (image diagnosis) Patients already inserted ENBD for future remnant liver lobe(s) and waiting periods more than 2 weeks to surgical operation. More than 10mm of bile duct length from edge of upstream stricture site to the first biliary branch PS(ECOG) 0 or 1 Adequate oral intake Estimated life expectancy more than 3 months With informed concent

Exclusion criteria

Exclusion criteria: Fever up more than 38 degree Severe neurologic impairment or mental disorder With severe other organ disorder Without another malignant disease Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Rate of cases who do not need stent exchange until surgical operation

Secondary

MeasureTime frame
Confirm the surgical operation safety and complication related stent and surgical operation of Fully Covered Metallic Stent for preoperative perihilar cholangiocarcinoma

Countries

Japan

Contacts

Public ContactHIroki Kawashima

Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology

h-kawa@med.nagoya-u.ac.jp0527442166

Outcome results

None listed

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