UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016331 |
|---|---|
| Receipt number | R000018951 |
| Scientific Title | Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2017/02/10 17:47:32 |
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Basic information
Public title
Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Acronym
Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Scientific Title
Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Scientific Title:Acronym
Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Region
| Japan |
Condition
Condition
Pancreatic carcinoma, Biliary carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This cohort study aimed to compare the diagnostic accuracy of contrast-enkhanecd harmonic EUS, standard EUS and color Doppler EUS in terms of differentiating malignant from benign lymph nodes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the diagnostic accuracy of standard EUS, color Doppler EUS and CH-EUS in terms of the ability to differentiate malignant nodes from benign nodes.
Key secondary outcomes
To compare the accuracy of CH-EUS and EUS-FNA in terms of N-stage diagnosis
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with lymphadenopathy detected by EUS
Cases with pancreatobiliary tumors confirmed by the other imag9ng methods.
Written informed consent
ECOG performance stautus = 0-2
Key exclusion criteria
Inapropriate to perform endoscopic ultrasonography
Faiulre of other organs (ASA: Grade 3, 4)
Inability to obtain informed consent
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
m-kitano@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
m-kitano@med.kindai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In consequtive patients with pancreatobiliary tumors acompanied by lymphadenopathy, contrast-enhanced harmonic EUS, conventional EUS and color Dopller EUS are perfrmed. Diagnostic abilities to identify lymph node metastases for all modalities are evaluated and compared.
Management information
Registered date
| 2015 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018951
