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

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 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

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

Value
https://center6.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