UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008438 |
|---|---|
| Receipt number | R000009909 |
| Scientific Title | Endoscopic ultrasound guided-fine needle aspiration for patient with suspected branch type intraductal papillary mucinous neoplasms |
| Date of disclosure of the study information | 2012/07/15 |
| Last modified on | 2014/01/14 16:44:36 |
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Basic information
Public title
Endoscopic ultrasound guided-fine needle aspiration for patient with suspected branch type intraductal papillary mucinous neoplasms
Acronym
EUS-FNA for patient with suspected branch type IPMN
Scientific Title
Endoscopic ultrasound guided-fine needle aspiration for patient with suspected branch type intraductal papillary mucinous neoplasms
Scientific Title:Acronym
EUS-FNA for patient with suspected branch type IPMN
Region
| Japan |
Condition
Condition
Branch duct type intraductal papillary mucinous neoplasms
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Evaluation of diagnostic accuracy in EUS-FNA for pancreatic cystic lesions.
2. Extraction of predictive factors about progression of lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Adequate sample collecion rate
Key secondary outcomes
2. Comparision of hisitopathological findings and immunohistochemical profile between EUS-FNA specimen and surgically resected specimen in patients with surgical resection.
3. Extraction of predictive factors about tumor progression in patients with diagnosed as benign IPMN and managed by observation.
4. Cyst fluid analysis using proteomics
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient with suspected branch type IPMN on MRCP and CT
2. Patients with written informed consent.
Key exclusion criteria
1. Patients with severely impaired organ function.
2. Patients with bleeding tendency (Plt < 50000, PT INR >= 1.5).
3. Patients with renal dysfunction (Cre >= 2.0).
4. Patient with allergy for contrast medium.
5. Patient who cant undergo MRCP because of metal inplant.
6. Patients with pregnancy.
7. Patients with malignant lesion in other organs.
8. Patients with active infection.
9. Patients with PS 4.
10. Patients with consciousness disorder.
11. Patients considered ineligible for this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Fourth Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL
011-611-2111
thayashi69@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Fourth Department of Internal Medicine
Zip code
Address
S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
thayashi69@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Fourth Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University Fourth Department of Internal Medicine
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
| 2012 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When Patient is diagnosed as malignancy or suspicious for malignancy, typical surgical resction is performed.
When Patient is diagnosed as benign, regular image examination (contrast enhanced CT, MRCP and EUS) was performed for two yaers.
Management information
Registered date
| 2012 | Year | 07 | Month | 14 | Day |
Last modified on
| 2014 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009909
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
