UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035906 |
|---|---|
| Receipt number | R000040736 |
| Scientific Title | Effect of temporary placement of fully covered metallic stent for stenosis of cholngiojejunostomy by using baloon-asisted rnteroscopy |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2019/02/16 14:16:44 |
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Basic information
Public title
Effect of temporary placement of fully covered metallic stent for stenosis of cholngiojejunostomy by using baloon-asisted rnteroscopy
Acronym
placement of fully covered metallic stent for cholngiojejunostomy
Scientific Title
Effect of temporary placement of fully covered metallic stent for stenosis of cholngiojejunostomy by using baloon-asisted rnteroscopy
Scientific Title:Acronym
placement of fully covered metallic stent for cholngiojejunostomy
Region
| Japan |
Condition
Condition
benign stenosis of cholangiojejunostomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate bougie effect of temporary placement of fully covered metallic stent on benign stenosis of cholangiojejunostomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of occurence of cholangitis and/or intrahepatic biliary stones after removal of fully covered metallic stent
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
| Maneuver |
Interventions/Control_1
temporal plaement of fully covered self-expandable metallic stant (FCSEMS) for choledochojejunal anastomotic stenosis
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. Lesion that require histological interpretation to obtain defenitive diagnosis
Age >=20 y
2. Ability to understand and willingness to sign a written statement of informed consent
Key exclusion criteria
a
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Teine Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL
011-681-8111
thayashi244@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Teine Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL
011-681-8111
Homepage URL
thayashi244@gmail.com
Sponsor or person
Institute
Center for Gastroenterology, Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Center for Gastroenterology, Teine Keijinkai Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 18 | 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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 18 | 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
| 2019 | Year | 02 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040736
