UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046530 |
|---|---|
| Receipt number | R000052516 |
| Scientific Title | Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2024/01/06 22:22:46 |
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Basic information
Public title
Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Acronym
Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Scientific Title
Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Scientific Title:Acronym
Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Region
| Japan |
Condition
Condition
Patients with distal biliary obstruction due to unresectable malignant tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of transpapillary biliary drainage using a long plastic stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction
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
Based on the length required to position the tip in the duodenojejunal flexure on fluoroscopic imaging, a 7.5Fr endoscopic nasobiliary drainage tube is cut.
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
20 years and more
Distal biliary obstruction due to unresectable malignant tumor, and biliary stenting is planned.
Key exclusion criteria
Surgically altered anatomy
Proximal biliary stricture
Performance status score of 4,
Serious complications in other organs (ASA category 3 and more)
Life expectancy less than 3 months.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto Second Red Cross Hospital
Division name
Gastroenterology
Zip code
602-8026
Address
355-5 Haruobi-cho, Kamigyo-ku, Kyoto city
TEL
0752315171
mndkchr@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto Second Red Cross Hospital
Division name
Gastroenterology
Zip code
602-8026
Address
355-5, Haruobi-cho, Kamigyo-ku, Kyoto city
TEL
0752315171
Homepage URL
mndkchr@gmail.com
Sponsor or person
Institute
Kyoto Second Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto Second Red Cross Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board (Kyoto Second Red Cross Hospital)
Address
355-5, Haruobi-cho, Kamigyo-ku, Kyoto city
Tel
0752315171
chiken2@kyoto2.jrc.or.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
| 2022 | Year | 01 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052516
