UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024939 |
|---|---|
| Receipt number | R000028616 |
| Scientific Title | Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study |
| Date of disclosure of the study information | 2016/11/28 |
| Last modified on | 2016/11/22 00:39:25 |
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Basic information
Public title
Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Acronym
Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Scientific Title
Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Scientific Title:Acronym
Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Region
| Japan |
Condition
Condition
recurrent benign stricture of choledochojejunal anastomosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence rate of stricture after the treatment
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 | Maneuver |
Interventions/Control_1
period of stent placement: 6 months
observation period: more than 1 years after stent removal
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) over 20 years old
2) recurrence case after treatment (endoscopic or percutaneous or surgical treatment)
3) patients who need treatment for obstructive jaundice, cholangitis, bile duct stones
Key exclusion criteria
1) Performance status 4
2) previous metal stent placement
3) malignant stricture
4) metal allergy
5) recurrence case of malignant tumor after surgery and life expectancy within 2 years
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kida Mitsuhiro |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamauchi |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
yhiroshi@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028616
