UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019490 |
|---|---|
| Receipt number | R000022537 |
| Scientific Title | Evaluation of diagnostic yield and post-ERCP pancreatitis in endoscopic pancreatic brush cytology |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2018/09/25 21:44:11 |
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Basic information
Public title
Evaluation of diagnostic yield and post-ERCP pancreatitis in endoscopic pancreatic brush cytology
Acronym
Transpapillary pancreatic brush cytology for pancreatic lesion
Scientific Title
Evaluation of diagnostic yield and post-ERCP pancreatitis in endoscopic pancreatic brush cytology
Scientific Title:Acronym
Transpapillary pancreatic brush cytology for pancreatic lesion
Region
| Japan |
Condition
Condition
pancreatic tumorous lesion with stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of diagnostic yield of brush cytology and
factor for Post-ERCP pancreatitis (PEP)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Factor for Post-ERCP pancreatitis (PEP)
Key secondary outcomes
Accuracy of panreatic brush cytology
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Between August 2008 and August 2014
A total of 88 consecutive patients with suspected pancreatic tumorous lesions who underwent endoscopic pancretic brush cytology
Key exclusion criteria
No specific exclusion criteria
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tesshin Ban |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8211
venzosan0204@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tesshin Ban |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8211
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
No funding
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
| 2015 | Year | 10 | Month | 26 | 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
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective trial
Management information
Registered date
| 2015 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022537
