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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007859
Receipt No. R000009203
Scientific Title Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Date of disclosure of the study information 2012/05/01
Last modified on 2017/05/02

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Basic information
Public title Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Acronym Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Scientific Title Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bukyo-ku, Tokyo
TEL 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Kogure
Organization JEIBIC Coordinating Office
Division name Department of Gastroenterology, Faculty of Medicine, The University of Tokyo
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 19 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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