UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027602 |
|---|---|
| Receipt number | R000031361 |
| Scientific Title | Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers |
| Date of disclosure of the study information | 2017/06/10 |
| Last modified on | 2019/06/10 21:05:23 |
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Basic information
Public title
Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers
Acronym
Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers
Scientific Title
Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers
Scientific Title:Acronym
Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the ability of contrast-enhanced harmonic EUS to detect liver metastases of patients with pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We conpare the diagnostic ability of contrast-enhanced harmonic EUS to detect liver metastases of patients with pancreatic cancer with that of harmonic EUS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic Ultrasound Sonography
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
over 20 years old
Patients with pancreati cancer diagnosed by imaging
Patients who agree with this study
patients whose ADL is good
Key exclusion criteria
Patients for which EUS is difficult
Patinents for which insertion of endoscopy is difficult
Patinets who have severe complication of other organs
patients who do not agree with this study
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama 641-0012
TEL
073-447-2300
Kitano@wakayma-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junya Nuta |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama 641-0012
TEL
073-447-2300
Homepage URL
jswnq633@yahoo.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
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
| 2017 | Year | 06 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031361
