Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction

Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction - RCT of IS and MS-SBS for MHBO

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034036

Enrollment

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

malignant hilar biliary obstruction

Interventions

side by side stenting using 6mm full-covered self expandable metallic stent inside stenting using plastic stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Untreated unresectable malignant hilar biliary obstruction 2. Type 2/3/4 in Bismuth classification 3. More than 3mg/dl of serum bilirubin 4. More than 20 years old 5. More than 30 days of expected survival period 6. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Patients with surgical altered anatomy or post-hepatectomy 2. Endoscopic approach to the biliary system is impossible 3. Prior biliary drainage (transient naso-biliary drainage can be included) 4. biliary obstruction to 3rd branch of bilateral bile duct 5. Pregnant women or those suspected of pregnancy 6. Patients considered ineligible by attending physicians

Design outcomes

Primary

Measure	Time frame
Time to Recurrent Biliary Obstruction	—

Secondary

Measure	Time frame
technical success rate, procedure time, functional success rate, adverse event, time of possible biliary drainage including re-intervention, survival time	—

Countries

Japan

Contacts

Public ContactToshifumi Kin

Teine-Keijinkai Hospital Center for Gastroenterology

kin_toshifumi@yahoo.co.jp011-681-8111

Outcome results

None listed

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