UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032607 |
|---|---|
| Receipt number | R000037080 |
| Scientific Title | Utility of contrast-enhanced endoscopic ultrasound screening for pancreatic lesion, mainly pancreatic cancer of chronic pancreatitis. A prospective study. |
| Date of disclosure of the study information | 2018/05/16 |
| Last modified on | 2020/05/18 08:58:33 |
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Basic information
Public title
Utility of contrast-enhanced endoscopic ultrasound screening for pancreatic lesion, mainly pancreatic cancer of chronic pancreatitis. A prospective study.
Acronym
Utility of contrast-enhanced endoscopic ultrasound for screening of chronic pancreatitis.
Scientific Title
Utility of contrast-enhanced endoscopic ultrasound screening for pancreatic lesion, mainly pancreatic cancer of chronic pancreatitis. A prospective study.
Scientific Title:Acronym
Utility of contrast-enhanced endoscopic ultrasound for screening of chronic pancreatitis.
Region
| Japan |
Condition
Condition
chronic pancreatitis, pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Early pancreatic cancer detection of patients with chronic pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection of pancreatic cancer
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform pancreatic cancer screening for chronic pancreatitis patients with contrast-enhanced endoscopic ultrasound.
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
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic pancreatitis diagnosed by clinical symptom, laboratory findings and imaging findings.
Patients who can be performed surgery when pancreatic cancer is detected.
Key exclusion criteria
Patients who are pregnant or have a possibility of pregnancy.
Patients who disagree informed consent.
Patient judged by doctor as inappropriate as subject participant of study.
Patients with egg allergy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo hospital
Division name
Department of Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2018 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037080
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| Registered date | File name |
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