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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047745
Receipt No. R000054430
Scientific Title Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/12

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Basic information
Public title Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Acronym Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Scientific Title Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Scientific Title:Acronym Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Region
Japan

Condition
Condition Anastomotic Biliary Stricture After Liver Transplantation
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the efficacy of covered self-expandable metallic stent (cSEMS) for patients with anastomotic biliary stricture after liver transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stricture resolution rate after cSEMS removal
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 cSEMS placement
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.patients with anastomotic biliary stricture who had duct- to-duct anastomosis after liver transplantation
Key exclusion criteria 1.Patients who can not receive endoscopic treatment 2.Patient with severe blood coagulation disorder 3.Patients with biliary stricture due to benign tumors 4.Patients who may have sensitization or allergic reactions to nitinol products
5.Patients who are pregnant or are likely to be pregnant, n ursing patients, and patients who wish to be pregnant duri ng the study period
6.In addition, patients who the research director has judge d inappropriate as a research subject
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Takahashi
Organization Nagasaki University Hospital
Division name Department of Gatroenterology and Hepatology
Zip code 852-8501
Address 1-7-1, Sakamoto Nagasaki
TEL 095-819-7481
Email takapochi0809@gmail.com

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Takahashi
Organization Nagasaki University Hospital
Division name Department of Gatroenterology and Hepatology
Zip code 852-8501
Address 1-7-1, Sakamoto Nagasaki
TEL 095-819-7481
Homepage URL
Email takapochi0809@gmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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 Nagasaki University Hospital Institutional Review Board
Address 1-7-1, Sakamoto Nagasaki
Tel 0958197229
Email gaibushikin@ml.nagasaki-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
2022 Year 05 Month 13 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2022 Year 07 Month 01 Day
Last follow-up date
2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054430

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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