UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060414 |
|---|---|
| Receipt number | R000068015 |
| Scientific Title | Impact of large-volume ascites on the outcomes of ERCP and EUS-guided biliary drainage in malignant biliary obstruction |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/01/20 17:59:34 |
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Basic information
Public title
Impact of large-volume ascites on the outcomes of ERCP and EUS-guided biliary drainage in malignant biliary obstruction
Acronym
Impact of large-volume ascites on the outcomes of ERCP and EUS-guided biliary drainage in malignant biliary obstruction
Scientific Title
Impact of large-volume ascites on the outcomes of ERCP and EUS-guided biliary drainage in malignant biliary obstruction
Scientific Title:Acronym
Impact of large-volume ascites on the outcomes of ERCP and EUS-guided biliary drainage in malignant biliary obstruction
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary outcome is the safety of ERCP and EUS-BD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is the safety of biliary drainage, as assessed by the incidence, type, timing, and severity of AEs.
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
malignant distal biliary obstruction
large-volume ascites
Key exclusion criteria
<20 years old
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Division name
Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
0928639759
takehikoga@gmail.com
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Koga |
Organization
Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Division name
Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
09083917399
Homepage URL
takehikoga@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
IRB of Fukuoka University
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Tel
0928011011
fu-merb-bigvan@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H25-04-005
Org. issuing International ID_1
IRB of Fukuoka University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Partially published
Result
URL related to results and publications
n/a
Number of participants that the trial has enrolled
156
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
| 2025 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
na
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068015
