UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051450 |
|---|---|
| Receipt number | R000058685 |
| Scientific Title | Efficacy and safety of endoscopic ultrasonography-guided embolization of gastric varices |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/06/26 12:34:53 |
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Basic information
Public title
Efficacy and safety of endoscopic ultrasonography-guided embolization of gastric varices
Acronym
Efficacy and safety of endoscopic ultrasonography-guided embolization of gastric varices
Scientific Title
Efficacy and safety of endoscopic ultrasonography-guided embolization of gastric varices
Scientific Title:Acronym
Efficacy and safety of endoscopic ultrasonography-guided embolization of gastric varices
Region
| Japan |
Condition
Condition
gastric varices
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will prospectively enroll patients undergoing endoscopic ultrasonography (EUS)-guided embolization of gastric varices to evaluate the efficacy, safety, and long-term postoperative course. We will then compare the results with those of other treatment methods, including retrograde transvenous embolization with balloon occlusion (BRTO), performed at our hospital in the past, in order to help establish appropriate treatment strategies for gastric varices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication of gastric varices.
Key secondary outcomes
Time required for the procedure. Incidence of adverse events such as postoperative bleeding, fever, and abdominal pain. Recurrence and rebleeding rates of esophagogastric varices. Mortality and liver transplantation rates.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-guided embolization of gastric varices
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
Present with gastric varices requiring treatment.
Key exclusion criteria
Patients who did not agree to participate
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81-52-744-2169
honda@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81-52-744-2169
Homepage URL
yokoshin@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya University Institutional Review Board
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
+81-52-744-2423
ethics@med.nagoya-u.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
| 2023 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058685
