UMIN-CTR Clinical Trial

Basic information
Public title	A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Acronym	A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Scientific Title	A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Scientific Title:Acronym	A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Region	Japan

Condition
Condition	Obstructive jaundice
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	When the metal stent is occluded, it is necessary to perform the stent placement endoscopically again, but it is often difficult to re-place the stent. Against this background, a stent delivery system induction device with extended function has become available in Japan, and the purpose is to prospectively examine cases in which retreatment was performed after stent occlusion and clarify the results.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary endpoint: Success rate of procedure The success rate of the procedure in this study is based on the case where stent placement can be finally performed using EndoSheather.
Key secondary outcomes	Secondary endpoints: clinical response rate, type and frequency of complications The clinical effect should be improved by T-bil <1.3 mg / dL or 50% or more of preoperative T-Bil. Early complications are complications that occur within 30 days, and late complications are complications that occur after that.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Period from the date of permission to conduct research to April 30, 2023
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	20 years old and over Obstructive jaundice case
Key exclusion criteria	Cases where there was an offer to refuse participation
Target sample size	20

Research contact person
Name of lead principal investigator	1st name miyano Middle name Last name akira
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Gastroenterology
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL	072-683-1221
Email	akira.miyano@opmu.ac.jp

Public contact
Name of contact person	1st name miyano Middle name Last name akira
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Gastroenterology
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL	072-683-1221
Homepage URL
Email	akira.miyano@opmu.ac.jp

Sponsor
Institute	Other
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Medical and Pharmaceutical University
Address	2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
Tel	072-683-1221
Email	akira.miyano@opmu.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	2021 Year 06 Month 25 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	2021 Year 06 Month 17 Day
Date of IRB	2021 Year 09 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2023 Year 04 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	2021 Year 06 Month 17 Day
Last modified on	2021 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050914