UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022673 |
|---|---|
| Receipt number | R000026133 |
| Scientific Title | A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors. |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2018/10/02 12:43:46 |
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Basic information
Public title
A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Acronym
Usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS)
Scientific Title
A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Scientific Title:Acronym
Usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS)
Region
| Japan |
Condition
Condition
Pancreatic tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of pancreatic tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To assess the diagnostic ability of CH-EUS in differential diagnosis of pancreatic tumors.
Key secondary outcomes
To compare the diagnostic ability of CH-EUS with that of conventional B-mode EUS and multidetector-row computed tomography (MDCT).
To assess the diagnostic ability of CH-EUS with TIC analysis in differential diagnosis of pancreatic tumors.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CH-EUS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients depicted Pancreatic mass using conventional EUS.
2)ECOG performance status = 0-1
3)Patients with adequate function of major organs
4)Patients who have provided written informed consent for participation in this study.
Key exclusion criteria
1)The patients who had an allergy to the contrast agent, Sonazoid.
2)The patients who had severe or uncontrolled concomitant systemic disorder.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama university hospital
Division name
Gastroenterology and hepatology
Zip code
Address
2-5-1, Shikata-cho, kita-ku, Okayama
TEL
086-235-7219
katou-h@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Yamamoto |
Organization
Okayama university hospital
Division name
Gastroenterology and hepatology
Zip code
Address
2-5-1, Shikata-cho, kita-ku, Okayama
TEL
086-235-7219
Homepage URL
Naokihiko@gmail.com
Sponsor or person
Institute
Okayama university hospital Gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
None
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
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026133
