UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059889 |
|---|---|
| Receipt number | R000068485 |
| Scientific Title | A study using existing data and information on EUS-HGS for malignant biliary obstruction. |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/11/26 17:07:08 |
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Basic information
Public title
A study using existing data and information on EUS-HGS for malignant biliary obstruction.
Acronym
A study using existing data and information on EUS-HGS for malignant biliary obstruction.
Scientific Title
A study using existing data and information on EUS-HGS for malignant biliary obstruction.
Scientific Title:Acronym
A study using existing data and information on EUS-HGS for 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
This study aims to clarify optimal treatment and management strategies for EUS-HGS based on clinical data, which is expected to enhance future treatment outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors affecting stent patency after EUS-HGS
Optimal method for re-intervention
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 who underwent EUS-HGS for malignant biliary obstruction between January 1, 2016, and March 31, 2025.
Key exclusion criteria
1. Patients under 20 years of age
2. Patients deemed unsuitable for treatment with EUS-HGS
3. Patients otherwise considered inappropriate for inclusion at the discretion of the physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Iwasa |
| Middle name | |
| Last name | Yuhei |
Organization
Gifu municipal hospital
Division name
gastroenterology
Zip code
500-8513
Address
gifu city, Kashima-cho, 7-1
TEL
058-251-1101
festinalenteyu@gmail.com
Public contact
Name of contact person
| 1st name | Iwasa |
| Middle name | |
| Last name | Yuhei |
Organization
Gifu municipal hospital
Division name
gastroenterology
Zip code
500-8513
Address
gifu city, Kashima-cho, 7-1
TEL
058-251-1101
Homepage URL
festinalenteyu@gmail.com
Sponsor or person
Institute
Gifu municipal hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
gifu municipal hospital
Address
Gifu city, Kashima-cho, 7-1
Tel
058-251-1101
festinalenteyu@gmail.com
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
| 2025 | Year | 11 | Month | 30 | 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
200
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study Period
Period of data collection (subjects): January 1, 2016 to March 31, 2025
Overall study period: From the date of approval until March 31, 2027
2. Study Design
Retrospective observational study.
3. Study Outline
For patients who underwent treatment using EUS-guided hepaticogastrostomy (EUS-HGS), the information described below will be collected from medical records and analyzed.
4. Observation and Laboratory Parameters / Data Collection Method
The following items will be obtained from the medical records. All items were collected as part of routine clinical practice:
Age
Sex
Primary disease
AST
ALT
Bilirubin
CRP
White blood cell count
Details of the procedure performed
Type of stent used
Stent occlusion rate
Time to occlusion
Treatment after occlusion
Adverse events
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068485
