UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027599 |
|---|---|
| Receipt number | R000031198 |
| Scientific Title | Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2022/01/31 17:08:21 |
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Basic information
Public title
Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Acronym
Efficacy of inside metallic stent for benign biliary stricture
Scientific Title
Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Scientific Title:Acronym
Efficacy of inside metallic stent for benign biliary stricture
Region
| Japan |
Condition
Condition
Benign biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stent placement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of stricture resolution at metallic stent removal after 4 month stent placement
Key secondary outcomes
1.Success rate of stent placement
2.Success rate of stent removal
3. Rate of stricture recurrence
4. Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with refractory benign biliary strictures (Resolution of stricture was not achieved by plastic stent treatment).
2.Malignancy is ruled out by pathological examination and clinical course.
3.Biliary stricture was completely existed on ERC findings, or no flow of contrast material into the downstream within 60 seconds, if stenosis was incomplete.
4.Biliary strictures located above the ampulla 15 mm or more upstream.(Metallic stent could be placed inside the bile duct )
Key exclusion criteria
1.Patients with performance status 3 or 4
2.Patients with severe complications to other organs.
3.Stricture of intrahepatic bile duct
4.Age<20
5.Patients without informed concent
6.The size of bile duct size showed less than 8 mm on first ERC finding.
7.Patients with severe coagulation dysfunction.
8.Patients with hepaticojejunostomy
9.Patients judged inappropriate by chief medical examiner.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
7008558
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
7008558
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
matsumotokazuyuki0227@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1,shikata-cho, okayama city, okayama
Tel
086-235-7219
mae6605@adm.okayama-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
| 2017 | Year | 06 | Month | 01 | 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
22
Results
The technical success rate of intraductal FCSEMS placement was 100%
The rate of successful stent removal at four months was 100% and stricture resolution was observed in 91% of patients.
Bile leak due to guidewire injury occurred in one patient, but stent migration or stent-induced de novo stricture did not occur in any patient.
The stricture recurrence rate was 16%, and the median(interquartile range)follow-up duration was 2.8(1.6-3.3)years.
1-year and 2-year recurrence free rate were 89% and 84%
Results date posted
| 2022 | Year | 01 | Month | 31 | Day |
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
| 2017 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observation period: 12 month(after metallic stent removal)
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031198
