UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054152 |
|---|---|
| Receipt number | R000061826 |
| Scientific Title | Inter-group Comparative Trial on the Efficacy and Safety of EIS (L) Monotherapy, Transvascular Embolization, and Mucosal Fibrosing Method by APC for Esophageal Varices |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/15 09:43:02 |
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Basic information
Public title
Consideration of Treatment Options for Esophageal Varices
Acronym
Consideration of Treatment Options for Esophageal Varices
Scientific Title
Inter-group Comparative Trial on the Efficacy and Safety of EIS (L) Monotherapy, Transvascular Embolization, and Mucosal Fibrosing Method by APC for Esophageal Varices
Scientific Title:Acronym
Inter-group Comparative Trial of Conservative Treatments for Esophageal Varices
Region
| Japan |
Condition
Condition
Esophageal Varices
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to demonstrate that the prognosis is improved by the Mucosal Fibrosing Method by investigating and examining whether the selected treatment is associated with the rates of bleeding recurrence and non-bleeding recurrence.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence rate of bleeding in esophageal varices
Key secondary outcomes
Morphological recurrence rate of esophageal varices, Survival time, Occurrence rate of adverse events and safety profile
Base
Study type
Others,meta-analysis etc
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
| 34 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From past medical records preserved at Dokkyo Medical University Hospital from 1 April 2010 through 31 July 2022, we extracted the data of 226 patients diagnosed with esophagogastric varices, including those who had completed treatment.
Key exclusion criteria
Based on the records, cases with gastric varices alone, those in which treatment was not completed by December 31, 2021, those treated with EVL alone, and those with bleeding were excluded.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.
TEL
0282-87-2147
yuka-t@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Suzuki |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.
TEL
0282-87-2147
Homepage URL
yuka-t@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University School of Medicine
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
Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.
Tel
0282-87-2147
yuka-t@dokkyomed.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
| 2024 | Year | 04 | Month | 17 | 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
98
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 05 | 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
This study is a retrospective study approved by the Ethics Committee of Dokkyo Medical University Hospital. This study will be conducted in accordance with the ethical principles based on the Declaration of Helsinki. The Ethics Committee of Dokkyo Medical University Hospital determined that since this is a retrospective study, written informed consent can be substituted with the obligation to provide information to the participants and the right to opt out to the participants. Statistical analyses were performed using software (SPSS v.28.0; IBM SPSS Inc.) Kaplan-Meier curves and Log Rank tests were used for time from end of treatment to morphologic recurrence and time from end of treatment to bleeding recurrence. Statistical significance was set at P<0.05. Statistical experts evaluated the statistics calculated for this study.
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061826
