UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047745 |
|---|---|
| Receipt number | 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 | 2023/11/15 18:22:12 |
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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
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
takapochi0809@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
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
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054430
