UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Title of the study (Brief title)	Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Region	Japan

Condition
Condition	Unresectable malignant hilar biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Step 1 To compare the efficacy of unilateral versus bilateral endoscopic nasobiliary drainage for unresectable malignant hilar biliary obstruction. Step 2 To compare the outcome of unilateral versus bilateral metallic stenting for unresectable malignant hilar biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	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)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Step 1 Unilateral endoscopic nasobiliary drainage Step 2 Unilateral endoscopic metallic stenting
Interventions/Control_2	Step 1 Bilateral endoscopic nasobiliary drainage Step 2 Bilateral endoscopic metallic stenting
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	166

Research contact person
Name of lead principal investigator	Hiroyuki Isayama
Organization	Faculty of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo, Bukyo-ku, Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	Hirofumi Kogure
Organization	JEIBIC Coordinating Office
Division name	Department of Gastroenterology, Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bukyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	kogureh-tky@umin.ac.jp

Sponsor
Institute	Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 19 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 28 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009203