UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028568 |
|---|---|
| Receipt number | R000032652 |
| Scientific Title | Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography |
| Date of disclosure of the study information | 2017/08/08 |
| Last modified on | 2017/08/08 09:17:50 |
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Basic information
Public title
Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Acronym
Minimal Ascites by EUS in Pancreatic Cancer
Scientific Title
Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Scientific Title:Acronym
Minimal Ascites by EUS in Pancreatic Cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether or not minimal ascites in preoperative assessment by EUS is prognostic factor for patients with pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the prognosis in patients with pancreatic cancer with or without minimal asicites in preoperaitve assessment by EUS
Key secondary outcomes
1 Detection rate of minimal ascites by EUS
2 Comparison of the detectability of minimal asictes by EUS and other image modarities.
3 Comparison of the prognosis in pancreatic cancer with minimal asictes in preoperative assessment of EUS and malignant cells in peritoneal 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patinets with pancreatic cancer who underwent the preoperative assessment by EUS and surgical resection.
Patinets with written informed consent.
Key exclusion criteria
Patients with ascites caused by other than panceatic cancer.
Patinets without written infromed consent.
Patinets considered ineligible for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL
81-43-222-7171
mikata@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL
81-43-222-7171
Homepage URL
mikata@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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 | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing paticular
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032652
