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 |
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)
Unilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Japan |
Unresectable malignant hilar biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Phase III
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)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
Step 1
Unilateral endoscopic nasobiliary drainage
Step 2
Unilateral endoscopic metallic stenting
Step 1
Bilateral endoscopic nasobiliary drainage
Step 2
Bilateral endoscopic metallic stenting
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
166
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
Faculty of Medicine, The University of Tokyo
Department of Gastroenterology
7-3-1 Hongo, Bukyo-ku, Tokyo
03-3815-5411
isayama-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Hirofumi Kogure |
JEIBIC Coordinating Office
Department of Gastroenterology, Faculty of Medicine, The University of Tokyo
7-3-1 Hongo, Bukyo-ku, Tokyo
03-3815-5411
kogureh-tky@umin.ac.jp
Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
None
Self funding
NO
2012 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 01 | Month | 19 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 04 | Month | 28 | Day |
2017 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009203