UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047907 |
|---|---|
| Receipt number | R000054611 |
| Scientific Title | Efficacy of contrast-enhanced endoscopic ultrasonography for differentiation of non-Hodgkin lymphoma |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/06/24 18:30:34 |
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Basic information
Public title
Efficacy of contrast-enhanced endoscopic ultrasonography for differentiation of non-Hodgkin lymphoma
Acronym
Contrast-enhanced endoscopic ultrasonography for non-Hodgkin lymphoma
Scientific Title
Efficacy of contrast-enhanced endoscopic ultrasonography for differentiation of non-Hodgkin lymphoma
Scientific Title:Acronym
Contrast-enhanced endoscopic ultrasonography for non-Hodgkin lymphoma
Region
| Japan |
Condition
Condition
non-Hodgkin lymphoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Differentiation of malignancy for non-Hodgkin's lymphoma by contrast-enhanced endoscopic ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of qualitative evaluation of contrast-enhanced EUS in differentiating the malignancy of non-Hodgkin's lymphoma
Key secondary outcomes
Efficacy of quantitative evaluation using TIC of contrast-enhanced endoscopic ultrasonography in differentiating the malignancy of non-Hodgkin's lymphoma
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
patients who were undergo EUS-FNA and contrast-enhanced EUS in the mediastinal or abdominal lymphadenopathy and diagnosed non Hodgkin's based on pathology obtained by EUS-FNA
Key exclusion criteria
long axis of lymph nodes as evaluated by B-mode EUS were less than 10mm, patient with potential allergy of contrast agent material, pregnant women, and failure of other organs
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Gifu University Hospital
Division name
First department of internal medicine
Zip code
501-1194
Address
1-1, yanagido, Gifu, Gifu
TEL
0582306000
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Yoshida |
Organization
Gifu Prefectural General Medical Center
Division name
Gastroenterology
Zip code
5008717
Address
4-6-1 Noishiki, Gifu-City, Gifu
TEL
0582461111
Homepage URL
kensakuyoshidaky@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36902841/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36902841/
Number of participants that the trial has enrolled
62
Results
When heterogeneous enhancement was defined as aggressive NHL, the sensitivity, specificity, and accuracy of the qualitative evaluation when using CE-EUS were 61%, 72%, and 66%, respectively. The sensitivity, specificity, and accuracy of CE-EUS in differentiating indolent NHL from aggressive NHL improved to 94%, 69%, and 82%, respectively, when combined with qualitative and quantitative evaluations.
Results date posted
| 2024 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
62 cases in which EUS-FNA was performed after contrast-enhanced EUS for mediastinal or intraperitoneal lymph node enlargement, and the final diagnosis was non-Hodgkin's lymphoma
Participant flow
In cases where malignant lymphoma is suspected based on blood tests, abdominal CT scans, etc. and there is enlargement of the mediastinal or intraperitoneal lymph nodes, contrast-enhanced EUS will be performed before EUS-FNA, and its diagnostic capability will be examined.
Adverse events
non
Outcome measures
To retrospectively evaluate the diagnostic ability of contrast-enhanced EUS in grading non-Hodgkin's lymphoma (indolent/aggressive)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively examined the ability of contrast-enhanced EUS to discriminate malignancy in patients who underwent contrast-enhanced EUS and EUS-FNA and were histologically diagnosed as non-Hodgkin's lymphoma.
Management information
Registered date
| 2022 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054611
