UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059083 |
|---|---|
| Receipt number | R000067584 |
| Scientific Title | Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis |
| Date of disclosure of the study information | 2025/09/13 |
| Last modified on | 2025/09/13 16:58:33 |
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Basic information
Public title
Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis
Acronym
Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis
Scientific Title
Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis
Scientific Title:Acronym
Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis
Region
| Japan |
Condition
Condition
Patients with esophageal varices
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will explore the efficacy and safety of esophageal variceal ligation (EVL) for patients with esophageal varices, comparing outpatient treatment with conventional additional inpatient treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Endpoints
Safety of outpatient esophageal variceal ligation
1. Post-treatment esophageal variceal bleeding rate
2. Post-treatment mortality rate
Key secondary outcomes
Secondary Endpoints
[Secondary Efficacy Endpoints]
1. Post-treatment recurrence rate during the observation period.
Definition of recurrence: ES morphology F1 or higher or RC sign observed on post-treatment endoscopic examination.
[Secondary Safety Endpoints]
1. Comparison of safety between initial and subsequent additional treatments.
Exploratory Endpoints
1. Correlation between patient characteristics and post-treatment esophageal variceal recurrence rate, esophageal variceal bleeding rate, and mortality rate.
2. Differences in recurrence rate due to prior esophageal variceal treatment and esophageal variceal bleeding history.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
1. Outpatient EVL Group (Prospective)
1) Patients for whom EVL treatment is indicated for esophageal varices
2) Patients aged 18 years or older at the time of consent
3) Patients who have received a thorough explanation of this study and, after fully understanding it, have provided their own voluntary written consent
2. Inpatient EVL Group (Retrospective)
1) Patients who underwent EVL as an inpatient at this facility between April 2022 and March 2025
Key exclusion criteria
Patients who meet any of the following criteria will not be eligible for this study.
1. Outpatient EVL Group (Prospective)
1. Patients who are deemed by the principal investigator or subinvestigator to be at high risk of bleeding and who should be hospitalized (patients with a varicose vein evaluation of F3 or RC3 or higher).
2. Patients undergoing regular medical care who the principal investigator or subinvestigator deems unsuitable for the safe implementation of this study.
2. Inpatient EVL Group (Retrospective)
1. Patients who received other treatments (e.g., EIS) concomitantly.
2. Patients whose treatment was discontinued after only one treatment.
3. Patients who expressed refusal to participate in this study through a disclosure document.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Nakamoto |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
0432227171
fujimoto.kentarou@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Fujimoto |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
0432227171
Homepage URL
fujimoto.kentarou@chiba-u.jp
Sponsor or person
Institute
Chiba Unoversity
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
Tel
0432227171
fujimoto.kentarou@chiba-u.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
| 2025 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will explore the efficacy and safety of esophageal variceal ligation (EVL) for patients with esophageal varices, comparing outpatient treatment with conventional additional inpatient treatment.
Management information
Registered date
| 2025 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067584
