UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020404 |
|---|---|
| Receipt number | R000023511 |
| Scientific Title | Incidence of biliary stricture after adult-to-adult living donor liver transplantation -role of biliary stent placement, a randomized controlled trial- |
| Date of disclosure of the study information | 2015/12/30 |
| Last modified on | 2016/01/04 13:32:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Incidence of biliary stricture after adult-to-adult living donor liver transplantation -role of biliary stent placement, a randomized controlled trial-
Acronym
Incidence of biliary stricture after adult-to-adult LDLT-role of biliary stent placement, a randomized controlled trial-
Scientific Title
Incidence of biliary stricture after adult-to-adult living donor liver transplantation -role of biliary stent placement, a randomized controlled trial-
Scientific Title:Acronym
Incidence of biliary stricture after adult-to-adult LDLT-role of biliary stent placement, a randomized controlled trial-
Region
| Japan |
Condition
Condition
liver failure
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Advantage of biliary stent placement still unknown.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of biliary stricture (within 2 years after liver transplantation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control
Interventions/Control_2
biliary stent placement
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult-to-adult living donor liver transplantation
Key exclusion criteria
Patients with biliary atresia and primary sclerosing cholangitis, graft with complex bile duct orifice were excluded from this study.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
jkaneko-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Kaneko |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
kanekoj-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Institute
Department
Personal name
Funding Source
Organization
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
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
Address
Tel
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
| 2015 | Year | 12 | Month | 30 | 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
Completed
Date of protocol fixation
| 2004 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023511
