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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038316
Receipt No. 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

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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
Email 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
Email yoshi-hk@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043666

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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