UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026627 |
|---|---|
| Receipt number | R000030574 |
| Scientific Title | The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope for detection of pancreatic diseases |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2019/03/07 14:53:53 |
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Basic information
Public title
The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope for detection of pancreatic diseases
Acronym
The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope for detection of pancreatic diseases
Scientific Title
The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope for detection of pancreatic diseases
Scientific Title:Acronym
The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope for detection of pancreatic diseases
Region
| Japan |
Condition
Condition
pancreatobiliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of endoscopic ultrasonography using newly developed endoscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy and the safety of endoscopic ultrasonography using newly developed endoscope
Key secondary outcomes
The findings acquired from newly developed endoscope
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Screen pancreas and biliary tract using newly developed endoscope during upper gastrointestinal endoscopy
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of 50 years and upward who undergo upper gastrointestinal endoscopy
Key exclusion criteria
Performance status = 3 or 4
Organ failure
Screened pancreas within a half year
Without the consent
Postoperative digestive tract
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Uchida |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
Homepage URL
d.uchida0309@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
| 2017 | Year | 05 | Month | 16 | 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
Intraoperative hypotension occurred as an adverse event of intravenous anesthesia in one patient. There were 82 pancreaticobiliary findings and 165 upper-gastrointestinal findings (malignancy not included). Follicular lymphoma of intra-abdominal lymph nodes was detected in one patient. The mean imaging scores of each section were 1.95 (pancreatic head and papilla), 2.0 (pancreatic body), 1.99 (pancreatic tail), and 1.89 (common bile duct and gallbladder). Age, history of diabetes mellitus, and smoking history were associated with the prevalence of pancreatic diseases significantly.
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
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030574
| 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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