UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023125 |
|---|---|
| Receipt number | R000026656 |
| Scientific Title | Risk factors for latent distant organ metastasis detected by staging laparoscopy in patients with radiologically defined locally advanced pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2016/07/12 00:11:15 |
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Basic information
Public title
Risk factors for latent distant organ metastasis detected by staging laparoscopy in patients with radiologically defined locally advanced pancreatic ductal adenocarcinoma
Acronym
Risk factors for latent distant organ metastasis in patients with locally advanced pancreatic ductal adenocarcinoma
Scientific Title
Risk factors for latent distant organ metastasis detected by staging laparoscopy in patients with radiologically defined locally advanced pancreatic ductal adenocarcinoma
Scientific Title:Acronym
Risk factors for latent distant organ metastasis in patients with locally advanced pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
data collected
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for latent distant organ metastasis in patients with radiographically defined locally advanced (RDLA) pancreatic ductal adenocarcinoma (PDAC).
Basic objectives2
Others
Basic objectives -Others
morbidity of latent distant organ metastasis in patients with RDLA-PDAC
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for latent distant organ metastasis in patients with radiographically defined locally advanced (RDLA) pancreatic ductal adenocarcinoma (PDAC).
Key secondary outcomes
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
radiographycally-defined locally advanced PDAC
Key exclusion criteria
Patients who denied staging laparoscopy
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD, FACS |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-5-1, Shin-machi, Hirakata OSAKA, JAPAN
TEL
+81-72-804-0101
satoi@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD, FACS |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-5-1, Shin-machi, Hirakata OSAKA, JAPAN
TEL
+81-72-804-0101
Homepage URL
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai medical university
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
| 2016 | Year | 07 | Month | 12 | 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
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | 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
The presence or not of minute distant organmetastasis using staging laparoscopy in patients with RDLA-PDAC
Management information
Registered date
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026656
