UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Acronym	RCT of IS and MS-SBS for MHBO
Scientific Title	Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Scientific Title:Acronym	RCT of IS and MS-SBS for MHBO
Region	Japan

Condition
Condition	malignant hilar biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the technical success, time to recurrent biliary obstruction, or re-intervention after recurrent biliary obstruction between inside stenting using plastic stent and side by side stenting using full-covered self expandable metallic stent
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to Recurrent Biliary Obstruction
Key secondary outcomes	technical success rate, procedure time, functional success rate, adverse event, time of possible biliary drainage including re-intervention, survival time

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	side by side stenting using 6mm full-covered self expandable metallic stent
Interventions/Control_2	inside stenting using plastic stent
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Untreated unresectable malignant hilar biliary obstruction 2. Type 2/3/4 in Bismuth classification 3. More than 3mg/dl of serum bilirubin 4. More than 20 years old 5. More than 30 days of expected survival period 6. Written informed consent obtained
Key exclusion criteria	1. Patients with surgical altered anatomy or post-hepatectomy 2. Endoscopic approach to the biliary system is impossible 3. Prior biliary drainage (transient naso-biliary drainage can be included) 4. biliary obstruction to 3rd branch of bilateral bile duct 5. Pregnant women or those suspected of pregnancy 6. Patients considered ineligible by attending physicians
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Toshifumi Middle name Last name Kin
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
Zip code	006-8555
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL	011-681-8111
Email	kin_toshifumi@yahoo.co.jp

Public contact
Name of contact person	1st name Toshifumi Middle name Last name Kin
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
Zip code	006-8555
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL	011-681-8111
Homepage URL
Email	kin_toshifumi@yahoo.co.jp

Sponsor
Institute	Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

Funding Source
Organization	None
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	Teine-Keijinkai Hospital
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
Tel	011-681-8111
Email	teine@keijinkai.or.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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 10 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	2018 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 05 Day
Last modified on	2019 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038800