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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026627
Receipt No. 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

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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
Email 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
Email d.uchida0309@gmail.com

Sponsor
Institute Okayama University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030574

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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