UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044178 |
|---|---|
| Receipt number | R000050452 |
| Scientific Title | Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2023/01/18 14:20:47 |
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Basic information
Public title
Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Acronym
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and fully covered SEMS for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Scientific Title
Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Scientific Title:Acronym
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and fully covered SEMS for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Region
| Japan |
Condition
Condition
Patients with non-resected distal malignant bile duct obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for unresected distal malignant bile duct stenosis using a multicenter, randomized, non-inferiority trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for non-resected distal malignant bile duct stenosis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two 10 French plastic stent placement
Interventions/Control_2
One fully covered self expandable metallic 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with unresected distal malignant bile duct stenosis who have already undergone initial PS implantation and whose cholangitis and jaundice have been confirmed to have improved.
2. Patients who are 20 years of age or older and have obtained written consent from themselves or a substitute.
3. Patients who can undergo endoscopic papillotomy without antithrombotic medication or with withdrawal of medication.
4. Patients with no history of SEMS placement.
5. The upper margin of the bile duct stenosis has a margin of at least 2 cm above the bifurcation.
6. Performance states 1, 2, 3.
Key exclusion criteria
1. Cases in which endoscopic retrograde cholangiography is difficult.
2. Patients with peri-hilar bile duct obstruction.
3. Patients with altered gastrointestinal
anatomy excluding Billroth-I reconstruction.
4. Patients with serious complications in other organs.
5. Performance status 4
6. Cases of pregnancy or possible pregnancy
7. Cases deemed inappropriate by the principal investigator or sub-investigator
8. Underage patients(less than 20 years old)
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University school of medicine
Division name
Department of Endoscopy
Zip code
105-08461
Address
3-25-8, Nishi-Shimbashi, Minato-ku Tokyo Japan
TEL
+81334331113181
ccl09720@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine, Tokyo, Japan
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku Tokyo Japan
TEL
+81334331113181
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
The Jikei University school of medicine
Institute
Department
Personal name
Funding Source
Organization
self-funding (The Jikei University school of medicine, Tokyo Japan)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Katsushika Medical Center, The Jikei University School of Medicine, Tokyo, Japan.
The Jikei University Kashiwa Hospital. Chiba, Japan
Atsugi City Hospital, Kanagawa Japan.
Fuji City General Hospital, Shizuoka Japan.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Committee of Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
Tel
+8133433111
rinri@jikei.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
東京慈恵会医科大学葛飾医療センター
東京慈恵会医科大学柏病院
厚木市立病院
富士市立中央病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 17 | 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
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2021 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050452
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| Registered date | File name |
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