UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025027 |
|---|---|
| Receipt number | R000028779 |
| Scientific Title | The efficacy and safety of non-flared fully covered self expandable metalic stent for benign biliary duct stricture |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2023/12/04 10:29:58 |
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Basic information
Public title
The efficacy and safety of non-flared fully covered self expandable metalic stent for benign biliary duct stricture
Acronym
The efficacy and safety of non-flared fully cSEMS for benign biliary duct stricture
Scientific Title
The efficacy and safety of non-flared fully covered self expandable metalic stent for benign biliary duct stricture
Scientific Title:Acronym
The efficacy and safety of non-flared fully cSEMS for benign biliary duct stricture
Region
| Japan |
Condition
Condition
Symptomatic benign biliary duct stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of non-flared FCSEMS for benign biliary duct stricture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of non-flared FCSEMS after placement for 6 months for benign biliary duct stricture
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
fully covered self-expandable metallic stent (FCSEMS) M-intraductal
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 over 20 years old
2) patients with symptomatic benign biliary stricture caused by such as surgery, ischemia, trauma, and chronic pancreatitis
3) patients with informed consent
Key exclusion criteria
1) Performance status < 4
2) patients be impossible to distinguish from IgG4 related disease and PSC
3) patients with severe hemorrhagic diathesis
4) patients with metal allergy
5) diameter of bile duct is 5mm or less
6) patients that the physician in charge consider not suitable for inclusion
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University Hospital
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
042-778-8111
t-iwai@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Iwai |
Organization
Kitasato University Hospital
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
042-778-8111
Homepage URL
t-iwai@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Ethics Committee Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
22
Results
The success rate of FCSEMS placement was 100% (22/22), and 81.8% (18/22) could be placed for 6 months. 19 of 22 patients were excluded, and the stenosis improvement rate was 89.5% (17/19), and the median bile duct diameter improved to 6.0 [1-9] mm. The median observation period after removal was 597 days [365-1651], and the recurrence rate was 5.9% (1/17).
Results date posted
| 2023 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 22 patients were enrolled, 13 with chronic pancreatitis (8 alcoholic, 5 non-alcoholic) and 9 with non-chronic pancreatitis.
Participant flow
After obtaining consent for treatment with FCSEMS for 6 months, FCSEMS was placed, and the primary endpoint was the stenosis release rate, and the other endpoints were the success rate of stenting, adverse events during stenting, whether FCSEMS could be removed, and the recurrence rate of stenosis, which was prospectively evaluated.
Adverse events
Adverse events during FCSEMS placement were 13.6% (3/22) (cholangitis/cholecystitis 2/1).
Outcome measures
The success rate of FCSEMS placement was 100% (22/22), and 81.8% (18/22) could be placed for 6 months. 19 of 22 patients were excluded, and the stenosis improvement rate was 89.5% (17/19), and the median bile duct diameter improved to 6.0 [1-9] mm. The median observation period after removal was 597 days [365-1651], and the recurrence rate was 5.9% (1/17).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 12 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028779
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