UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019936 |
|---|---|
| Receipt number | R000023021 |
| Scientific Title | A clinical role of staging laparoscopy in patients with radiographically defined locally advanced pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2015/11/26 |
| Last modified on | 2015/11/26 09:43:49 |
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Basic information
Public title
A clinical role of staging laparoscopy in patients with radiographically defined locally advanced pancreatic ductal adenocarcinoma
Acronym
staging laparoscopy in patients with locally advanced pancreatic ductal adenocarcinoma
Scientific Title
A clinical role of staging laparoscopy in patients with radiographically defined locally advanced pancreatic ductal adenocarcinoma
Scientific Title:Acronym
staging laparoscopy in patients with locally advanced pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
radiographically defined locally advanced pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the rate of occult distant organ metastasis, conparison of survival rate according to the site of occult distant organ metastasis, and risk factors for occult distant organ metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to analyze risk factors for occult distant organ metastasis in patients with radiographically-defined locally advanced pancreatic ductal adenocarcinoma.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
staging laparoscopy for diagnosing occult distant organ metastasis
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
1. radiographically-defined locally advanced pancreatic ductal adenocarcinoma
2. Obtained informed consent
3. tolerable for general anesthesia
Key exclusion criteria
1. Patients who cannot understand informed consent
2. pregnant patients
3. Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-5-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
072-804-0101
satoi@hriakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-5-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
072-804-0101
Homepage URL
satoi@hriakata.kmu.ac.jp
Sponsor or person
Institute
Department of Surgery, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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 | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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
Management information
Registered date
| 2015 | Year | 11 | Month | 26 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023021
