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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027239
Receipt No. R000025608
Scientific Title Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type
Date of disclosure of the study information 2017/05/03
Last modified on 2019/05/05

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Basic information
Public title Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type
Acronym RCT of covered SEMS for MBS: Braded vs Laser-cut type
Scientific Title Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type
Scientific Title:Acronym RCT of covered SEMS for MBS: Braded vs Laser-cut type
Region
Japan

Condition
Condition unresected malignancies causing lower or middle biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Many have reported the utility of endoscopic treatment using self-expanded metallic stent (SEMS) for lower or middle biliary stricture caused by malignancies.
There are two types in SEMS, Braded and Laser-cut type, and they have each different feature. In the present study, we will prospectively compare and estimate the clinical outcomes between the two types of SEMS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of stent dysfunction one year after stent intervention
Key secondary outcomes safety, success rate, time of stent patency, overall time of survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention: Laser-cut type of SEMS
Interventions/Control_2 Control: Braded type of SEMS
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) Patients' age of more than 20 years-old.
2) Patients having lower or middle biliary stricture caused by unresectable malignancies
3) Patients having dilation of bile duct and cholangitis, obstructive jaundice or liver dysfunction.
4) Patients who are judged appropriate for endoscopic biliary stenting using metallic stent by chief (responsive) medical examiner.
5) Written informed consent is obtained from patient before the study.
Key exclusion criteria 1) Patients' age of less than 20 years-old.
2) Patients having resectable malignancies.
3) Written informed consent is not obtained from patient before the study.
4) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takamitsu
Middle name
Last name Sato
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL +81-45-787-2640
Email tasatou-ykh@umin.ac.jp

Public contact
Name of contact person
1st name Takamitsu
Middle name
Last name Sato
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL +81-45-787-2640
Homepage URL
Email tasatou-ykh@umin.ac.jp

Sponsor
Institute Yokohama city university Hospital
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 Yokohama CIty University
Address 1-1-1 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
Tel +81-45-370-7629
Email nextjim1@yokohama-cu.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
2017 Year 05 Month 03 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
2016 Year 04 Month 30 Day
Anticipated trial start date
2016 Year 06 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
2017 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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