UMIN-CTR Clinical Trial

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