UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049224 |
|---|---|
| Receipt number | R000056063 |
| Scientific Title | A multicenter prospective study of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage for the treatment of unresectable malignant biliary obstruction in patients with surgically altered anatomy |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2022/10/14 21:11:32 |
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Basic information
Public title
A multicenter prospective study of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage for the treatment of unresectable malignant biliary obstruction in patients with surgically altered anatomy
Acronym
A multicenter prospective study of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage
Scientific Title
A multicenter prospective study of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage for the treatment of unresectable malignant biliary obstruction in patients with surgically altered anatomy
Scientific Title:Acronym
A multicenter prospective study of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage
Region
| Japan |
Condition
Condition
malignant biliary obstruction in patients with surgically altered anatomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of endoscopic ultrasound guided biliary drainage and balloon endoscopic biliary drainage of unresectable malignant biliary obstruction in patients with surgically altered anatomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients over 20 years old
Patients with unresectable malignant biliary obstruction with surgically altered anatomy who will proceed to endoscopic ultrasound-guided biliary drainage or balloon endoscopic biliary drainage
Key exclusion criteria
Patients who are judged to be inappropriate as study subjects by the study investigator (sub investigator)
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama medical university
Division name
The second internal medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Hatamaru |
Organization
Wakayama medical university
Division name
The second internal medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
Homepage URL
papepo51@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
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
Wakayama medical university
Address
The second internal medicine
Tel
073-447-2300
papepo51@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 14 | 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
94
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational study of the technical success of endoscopic ultrasound-guided biliary drainage versus balloon endoscopic biliary drainage
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056063
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
