UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006408 |
|---|---|
| Receipt number | R000007603 |
| Scientific Title | EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis. |
| Date of disclosure of the study information | 2011/10/30 |
| Last modified on | 2016/08/25 12:13:33 |
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Basic information
Public title
EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Acronym
EUS-FNA study for preoperative pancreato-biliary cancers
Scientific Title
EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Scientific Title:Acronym
EUS-FNA study for preoperative pancreato-biliary cancers
Region
| Japan |
Condition
Condition
pancreatic cancer, biliary tract cancer
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of EUS-FNA as preoperative method for paraaortic lymph node metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Evaluate the efficacy of EUS-FNA for paraaortic lymph nodes.
Key secondary outcomes
(1) comparison with FDG-PET, (2)complications, (3) quality of specimen material
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The number of patients until Des 2016.
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) Preoperative state of pancreatic cancer or bliary tract cancer,
(2) PS1 or 2
Key exclusion criteria
(1) Patients who have allergy for contrast medium
(2) Patients with bleeding tendency
(3) Patients under anticoaglant therapy
(4) Plt< 30000
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Chiba |
Organization
Kyoto University
Division name
Department of gastroenterology ahd hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
chiba@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Kyoto University
Division name
Department of gastroenterology ahd hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
akurita@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of gastroenterology ahd hepatology, Kyoto 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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 26 | Day |
Last modified on
| 2016 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007603
