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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044178
Receipt No. 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 2021/08/02

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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
Email 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
Email ccl09720@gmail.com

Sponsor
Institute The Jikei University school of medicine
Institute
Department

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
Email 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
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
2021 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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