UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005980 |
|---|---|
| Receipt number | R000005410 |
| Scientific Title | The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor |
| Date of disclosure of the study information | 2011/07/15 |
| Last modified on | 2015/01/10 18:40:31 |
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Basic information
Public title
The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor
Acronym
Endoscopic Ultrasound-guided fine Needle aspiration Of Pancreatic Cancer Study (EUNOS-PC)
Scientific Title
The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor
Scientific Title:Acronym
Endoscopic Ultrasound-guided fine Needle aspiration Of Pancreatic Cancer Study (EUNOS-PC)
Region
| Japan |
Condition
Condition
pancreatic solid tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the evaluation of the efficacy and safety of EUS-FNA for pancreatic solid tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity of EUS-FNA for pancreatic solid tumors
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
# Patients with pancreatic solid tumors
# Patients who understand the aim of this study
# Patients who had not undergone EUS-FNA yet
# Japanese
Key exclusion criteria
# Patients who have tendency of bleeding
# The lesion cannot be demonstrated
# Patients who have the high risk of complication by EUS-FNA
# There are some definite vessels between EUS and lesions
# The movement by breathing may cause puncture of another organs
# Patients with pancreatic cystic lesions
# Patients who don't understand the aim of this study
# EUS-FNA doesn't help to decide the treatment
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetaka Yoshinaga |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
shiyoshi@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetaka Yoshinaga |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
shiyoshi@ncc.go.jp
Sponsor or person
Institute
Clinical application of the new technology for endoscopic diagnosis and researches on the improvement of the diagnostic accuracy
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立がん研究センター中央病院（東京都）、東京医科大学病院（東京都）、福島県立医科大学附属病院（福島県）、愛知県がんセンター中央病院（愛知県）、岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 15 | 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
| 2010 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
We evaluate efficacy and complications of EUS-FNA for pancreatic solid tumors.
We observe about patients' condition 1 week after EUS-FNA.
Management information
Registered date
| 2011 | Year | 07 | Month | 15 | Day |
Last modified on
| 2015 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005410
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2015/01/10 | 150110EUNOS生データ_デポジトリ用.xlsx |
