UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036910 |
|---|---|
| Receipt number | R000042061 |
| Scientific Title | Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Living Donor Liver Transplantation |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2023/06/04 19:32:41 |
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Basic information
Public title
Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Living Donor Liver Transplantation
Acronym
Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Living Donor Liver Transplantation
Scientific Title
Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Living Donor Liver Transplantation
Scientific Title:Acronym
Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Living Donor Liver Transplantation
Region
| Japan |
Condition
Condition
Anastomotic Biliary Stricture After Living Donor 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 living donor 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/Plastic stent
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 living donor 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, nursing patients, and patients who wish to be pregnant during the study period
6.In addition, patients who the research director has judged inappropriate as a research subject
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Komatsu |
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
n_komatsu0822@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Komatsu |
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
n_komatsu0822@yahoo.co.jp
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/deo2.225
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/deo2.225
Number of participants that the trial has enrolled
9
Results
The FCSEMS placements were successful in all nine cases. Four patients experienced mild cholangitis, which was resolved with conservative treatment. Additionally, there was one case of distal migration. The FCSEMSs were successfully removed from all the patients, and the clinical success rate was 100%. Stricture recurrence occurred in one (11.1%) patient during the follow-up period.
Results date posted
| 2023 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 27 | Day |
Baseline Characteristics
The background of the nine patients in the study was a median age of 63 years (49-73), with six males and three females. Viral cirrhosis was the most common primary disease (7 patients), and Seven patients had hepatocellular carcinoma before the LDLT. The grafts were right lobe in one case and left lobe in eight cases. The median time to ABS onset was 5 months (3-32 months).
Participant flow
We placed a short FCSEMS with a long lasso and middle waist formation in each patient's ABS above the papilla and removed it 16 weeks later.
Adverse events
Cholangitis occurred in four patients (44.4%) as an early AE; however, all the cases were mild and resolved with conservative antibiotic treatment. No pancreatitis was observed. Distal migration of the FCSEMS occurred in one case, although it remained in the bile duct and stricture resolution occurred without re-intervention. Proximal migration of the FCSEMS or FCSEMS-induced strictures was not observed.
Outcome measures
Clinical success rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042061
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/04 | 生体肝移植後胆管狭窄に対する自己拡張型金属ステントの有用性 計画書5.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
