Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)

Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial) - Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007859

Enrollment

166

Registered

2012-05-01

Start date

2012-06-01

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 malignant hilar biliary obstruction

Interventions

Step 1 Unilateral endoscopic nasobiliary drainage Step 2 Unilateral endoscopic metallic stenting Step 1 Bilateral endoscopic nasobiliary drainage Step 2 Bilateral endoscopic metallic stentin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Step 1 1) Unresectable malignant hilar biliary obstruction of Bismuth type II or higher. 2) Initial biliary drainage. 3) The level of total bilirubin is more than 3mg/dl. 4) Patients with predictable prognosis of more than 30 days. 5) Patients with written informed consent. Step 2 Of the patients were registered in Step 1, 1) Reduction in bilirubin to <50% of the pretreatment value or normalization, and improvement of cholangitis within 1 week after initial drainage. 2) Although ENBD was added because of insufficient biliary drainage, bilirubin was reduced to <50% of the pretreatment value or normalized within 2 weeks after initial drainage. 3) Although ENBD was added because of cholangitis, cholangitis was improved within 2 weeks after initial drainage.

Exclusion criteria

Exclusion criteria: 1) Patients after gastrectomy with Roux-en-Y reconstruction or Billroth II reconstruction. 2) Patients with marked hemiliver atrophy or patients after hepatectomy. 3) Separate obstructions of fourth-order or smaller biliary branches. 4) Patients with severe acute cholangitis. 5) Pregnant or breast-feeding women. 6) Patients considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
Step 1 Functional success rate (Successful drainage was defined as reduction in bilirubin to <50% of the pretreatment value or normalization within 1 week after drainage.) Step 2 Time to stent dysfunction (ingrowth, overgrowth, sludge formation, and cholangitis)	—

Secondary

Measure	Time frame
Step 1 1) Technical success rate 2) Bilirubin decrease rate 3) Complication rate 4) Additional drainage rate Step 2 1) Technical success rate 2) Early and late complications 3) Stent patency period 4) Survival period 5) Success rate of reintervention	—

Countries

Japan

Contacts

Public ContactHirofumi Kogure

JEIBIC Coordinating Office Department of Gastroenterology, Faculty of Medicine, The University of Tokyo

kogureh-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

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