UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031373 |
|---|---|
| Receipt number | R000035824 |
| Scientific Title | Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor |
| Date of disclosure of the study information | 2018/02/19 |
| Last modified on | 2019/02/02 00:13:58 |
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Basic information
Public title
Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Acronym
Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Scientific Title
Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Scientific Title:Acronym
Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Region
| Japan |
Condition
Condition
Lesions of gastro-intestinal tract, pancreatobiliary and lymph node needed endoscopic ultrasonography(EUS) and EUS-FNA
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to verify which is useful EU-ME2/UCT-260 or SU-1/EG-580UT in EUS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drawability of EUS
Key secondary outcomes
Insertability and visibility for GI tract.
Complication due to this study.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A doctor who has experienced EUS and EUS-FNA for more than 3 years perform EUS (using EU-ME2) in outpatient or inpatient, and EUS-FNA (using SU-1) in inpatient. Image findings, scope insertability, and visibility for GI tract are evaluated by crossover. EUS will be performed within 4 weeks after consent acquisition and EUS-FNA within 8 weeks after acquiring consent. If there is no problem after the examination, the patient will be discharged.
Interventions/Control_2
A doctor who has experienced EUS and EUS-FNA for more than 3 years perform EUS (using SU-1) in outpatient or inpatient, and EUS-FNA (using EU-ME2) in inpatient. Image findings, scope insertability, and visibility for GI tract are evaluated by crossover. EUS will be performed within 4 weeks after consent acquisition and EUS-FNA within 8 weeks after acquiring consent. If there is no problem after the examination, the patient will be discharged.
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)Men and women over 20 years old at the time we acquire informed consent
2)Patient who require EUS and EUS-FNA clinically(below)
Those who suspect the presence of lesions in the gastrointestinal tract, gall bladder / bile duct, pancreas, lymph node and need detailed observation.
Those who needs histopathological diagnosis of lesion.
Those who judged clinically that EUS / EUS-FNA is necessary other than the above.
Key exclusion criteria
1) Those who cannot obtain informed consent from this research.
2) Women who may be pregnant or have a possibility of pregnancy.
3) Those who judged inappropriate patient as research subject by the research doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Tottori University Hospital
Division name
Department of Gastroenterology
Zip code
Address
86 Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6527
isomoto@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Koda |
Organization
Tottori University Hospital
Division name
Department of Gastroenterology
Zip code
Address
86 Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6527
Homepage URL
po.polnga.3.negaiwo.xxx@gmail.com
Sponsor or person
Institute
Tottori University
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 19 | 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
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035824
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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