UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009885 |
|---|---|
| Receipt number | R000011580 |
| Scientific Title | Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography |
| Date of disclosure of the study information | 2013/01/30 |
| Last modified on | 2017/03/02 11:44:05 |
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Basic information
Public title
Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography
Acronym
Cholangiocarcinoma with slight ascites in EUS
Scientific Title
Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography
Scientific Title:Acronym
Cholangiocarcinoma with slight ascites in EUS
Region
| Japan |
Condition
Condition
Cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether slight ascites in preoperative assessment of endoscopic ultrasonography affect the prognosis of patients with cholangiocarcinoma.
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 cholangiocarcinoma with and without slight ascites in preoperative assessment of endoscopic ultrasonography
Key secondary outcomes
: Detection rate of slight ascites in endoscopic ultrasonography.
: Comparison of the detectability of slight ascites in endoscopic ultrasonography and other imaging modarities.
: Comparison of the prognosis in cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography 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
: Patients with cholangiocarcinoma who underwent the preoperative assessment of endoscopic ultrasonography and surgical resection.
: Patients with written informed consent.
Key exclusion criteria
: Patients with ascites caused by other than cholangiocarcinoma.
: Patients without written informed consent.
: Patients considered ineligible for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tsuyuguchi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan
TEL
81-43-222-7171
igaku-rinri@office.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Tsuyuguchi |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan
TEL
81-43-222-7171
Homepage URL
igaku-rinri@office.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
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
| 2013 | Year | 01 | Month | 30 | 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
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2013 | Year | 01 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011580
