UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060074 |
|---|---|
| Receipt number | R000056521 |
| Scientific Title | Efficacy of contrast-enhanced harmonic EUS for gallbladder tumor |
| Date of disclosure of the study information | 2025/12/13 |
| Last modified on | 2025/12/12 18:16:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of contrast-enhanced harmonic EUS for gallbladder tumor
Acronym
Efficacy of contrast-enhanced harmonic EUS for gallbladder tumor
Scientific Title
Efficacy of contrast-enhanced harmonic EUS for gallbladder tumor
Scientific Title:Acronym
Efficacy of contrast-enhanced harmonic EUS for gallbladder tumor
Region
| Japan |
Condition
Condition
gallbladder tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic capability in terms of differentiating malignant from benign for gallbladder tumor with contrast-enhanced EUS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether contrast-enhanced harmonic EUS improves the accuracy of differentiating benign from malignant gallbladder tumors compared to B-mode EUS
Key secondary outcomes
The optimal evaluation method for gallbladder tumors in differentiating malignant from benign with contrast-enhanced harmonic EUS
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Long axis of lymph node <10 mm
*Pathological diagnosis obtained by surgery or EUS-FNA
Key exclusion criteria
*Cases with obvious distant metastasis or local invasion
*Blood coagulation disorder or a platelet
count of less than 50,000/uL
*Taking anticoagulant or antiplatelet drugs
*Pregnancy
*Egg allergy
*Failure of other organs
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Yoshida |
Organization
Gifu Prefectural General Medical Center
Division name
Gastroenterology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu-City
TEL
0582461111
kensakuyoshidaky@gmail.com
Public contact
Name of contact person
| 1st name | Yoshida |
| Middle name | |
| Last name | Kensaku |
Organization
Gifu Prefectural General Medical Center
Division name
Gastroenterology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu-City
TEL
0582461111
Homepage URL
kensakuyoshidaky@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Gifu Prefectural General Medical Center
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 University Hospital
Address
1-1, yanagido, Gifu, Gifu
Tel
0582306000
takuji@w7.dion.ne.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 | 12 | 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
86
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
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A total of 86 patients were enrolled, and the analysis has been completed.
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056521
