UMIN-CTR Clinical Trial

Basic information
Public title	Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Acronym	Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Scientific Title	Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Scientific Title:Acronym	Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility and efficacy of the novel multi-stenting technique for high-grade malignant hilar biliary obstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patient with high-grade unresectable malignant hilar biliary obstruction which require biliary drainage
Key exclusion criteria	1) Patients having difficulty in transpapillary approach 2) Patients with surgically altered anatomy 3) Re-intervention 4) Ptients with small diameter common bile duct 5) Patients with performance status 4 6) Patients with severe comorbiditeis in any other organs 7) Pregnant women or those suspected of pregnancy 8) Patients without informed consent 9) Inappropriate patients for entry on this study in the judgement of their research investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tadahisa Middle name Last name Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561623311
Email	tinoue-tag@umin.ac.jp

Public contact
Name of contact person	1st name Tadahisa Middle name Last name Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561623311
Homepage URL
Email	tinoue-tag@umin.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi Medical University
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	Aichi Medical University
Address	1-1 Yazakokarimata Nagakute Aichi
Tel	0561623311
Email	kanrika@aichi-med-u.ac.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	2020 Year 01 Month 24 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 12 Month 25 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2020 Year 01 Month 24 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the effeicacy and safety of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions

Management information
Registered date	2020 Year 01 Month 24 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044764