UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021261 |
|---|---|
| Receipt number | R000024524 |
| Scientific Title | Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2022/03/15 21:01:43 |
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Basic information
Public title
Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation
Acronym
Metal stenting for biliary strictures after liver transplantation
Scientific Title
Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation
Scientific Title:Acronym
Metal stenting for biliary strictures after liver transplantation
Region
| Asia(except Japan) |
Condition
Condition
Benign biliary stricture after liver transplantation
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of intraductal placement of non-flared fully covered self-expandable metallic stent for refractory biliary stricture after living donor liver transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stricture resolution: significant increase the diameter of stricture site and complete runoff of contrast after stent 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
metal stenting for 3 months
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Clinical symptoms of bile duct obstruction with jaundice
2. Documented benign biliary stricture after living donor liver transplantation
3. Refractory to balloon dilation and plastic stenting
Key exclusion criteria
1. Documented malignant bile duct stricture
2. Multiple strictures of the bile duct
3. Surgically altered gastrointestinal anatomy
4. Bleeding tendency or any contraindications for ERCP
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jong Ho |
| Middle name | |
| Last name | Moon |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
14584
Address
170 Jomaru-ro, Wonmi-gu, Bucheon
TEL
+82-32-621-5094
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | Hyun Jong |
| Middle name | |
| Last name | Choi |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
14584
Address
170 Jomaru-ro, Wonmi-gu, Bucheon
TEL
+82-32-621-5211
Homepage URL
joseph@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No specific funding source
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SoonChunHyang University Bucheon Hospital Institutional Review Board
Address
170 Jomaru-ro, Wonmi-gu, Bucheon
Tel
+82-32-621-6362
irb@schmc.ac.kr
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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31418477/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31418477/
Number of participants that the trial has enrolled
32
Results
Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23-118 days).
Results date posted
| 2022 | Year | 03 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male 26 (81.3)Female 6 (18.7)
Indications for living donor liver transplantation
Hepatocellular carcinoma 12 (37.4)
Viral liver cirrhosis 10 (31.3)
Alcoholic liver cirrhosis 6 (18.8)
Primary biliary cholangitis 4 (12.5)
Type of stricture
Anastomotic 31 (96.9)
Non-anastomotic 1 (3.1)
Location of stricture, number (percent)
Common hepatic duct 22 (68.8)
Hilum 8 (25.0)
Common bile duct 2 (6.2)
Participant flow
A total of 32 consecutive patients with symptomatic ABS after LDLT unresolved by plastic stents with or without balloon dilation at four tertiary medical centers were prospectively enrolled. A short (3 or 5 cm) FCSEMS having long lasso (10 cm) used in this study had unflared convex ends to minimize tissue hyperplasia and smaller center portion to prevent migration. The FCSEMS was placed above the papilla and removed at 3-4 months after stenting.
Adverse events
Early stent migration was observed in five (15.6%) patients. However, three patients with early stent migration had stricture resolution without needing additional intervention. No stent-induced ductal change was observed in all patients. Stricture recurrence was observed in 11.5% (3/26) of patients during 639 days of median duration of follow-up (range, 366-2079 days).
Outcome measures
Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23-118 days).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024524
