UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038316 |
|---|---|
| Receipt number | R000043666 |
| Scientific Title | Randomized Controlled Trial on Clinical Outcomes of EUS-guided Biliary Drainage vs. Balloon-enteroscopy-assisted ERCP for Malignant Biliary Obstruction |
| Date of disclosure of the study information | 2019/10/16 |
| Last modified on | 2019/10/16 19:15:28 |
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Basic information
Public title
Randomized Controlled Trial on Clinical Outcomes of EUS-guided Biliary Drainage vs. Balloon-enteroscopy-assisted ERCP for Malignant Biliary Obstruction
Acronym
Red Ball Study
Scientific Title
Randomized Controlled Trial on Clinical Outcomes of EUS-guided Biliary Drainage vs. Balloon-enteroscopy-assisted ERCP for Malignant Biliary Obstruction
Scientific Title:Acronym
Red Ball Study
Region
| Japan |
Condition
Condition
Biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Biliary drainage for malignant obstruction in patients after surgically-altered anatomy is challenging. Recently, balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) and endoscopic ultrasonography (EUS)-guided biliary drainage (EUS-BD) have become feasible. However, it has been unknown which technique is favorable.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall procedure time
Key secondary outcomes
Success rate of biliary decompression, adverse events, recurrence of biliary obstruction, number of reintervention, survival period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-BD
Interventions/Control_2
BE-ERCP
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a. malignant biliary obstruction
b. surgically-altered anatomy except Billroth-I reconstruction
c. total biliarubin (TB) >/= 2.0 mg/dL
d. no previous biliary stenting
e. condition applicable for both interventions
f. written IC
Key exclusion criteria
a. impossibility for endoscopic therapy
b. poor general condition, ASA class 4 or poorer.
c. extremely poor condition due to malignancy
d. condition in which either intervention cannot be applicable
e. condition in which either intervention is obviously favorable
f. previous EUS-BD, BE-ERCP, ERCP, or percutaneous biliary drainage
g. previous registration to this study
h. elevated TB level derived from diseases other than biliary obstruction, such as hemolysis
i. allergy for a contrast agent
j. pregnancy
k. impossibility for observation after treatment
l. at doctor's discretion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-252-1111
yoshi-hk@openhp.or.jp
Public contact
Name of contact person
| 1st name | Yoshihide |
| Middle name | |
| Last name | Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-252-1111
Homepage URL
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Review Board of Sendai City Medical Center
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
Tel
022-252-1111
yoshihk44@yahoo.co.jp
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
仙台市医療センター（宮城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043666
