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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009203