UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007859 |
|---|---|
| Receipt number | 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 13:13:14 |
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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
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
kogureh-tky@umin.ac.jp
Sponsor or person
Institute
Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009203
