UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028569 |
|---|---|
| Receipt number | R000032699 |
| Scientific Title | Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study |
| Date of disclosure of the study information | 2017/08/09 |
| Last modified on | 2017/08/08 10:14:11 |
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Basic information
Public title
Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Acronym
EUS evaluation of vascular invasion in pancreatic cancer
Scientific Title
Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Scientific Title:Acronym
EUS evaluation of vascular invasion in pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to analyses EUS signs of peripancreatic arterial and venous invasion in pancreatic carcinoma.
Since EUS tends to cause a difference in diagnostic accuracy by the operator, so in order to unify expressions between operators, we evaluated with the check sheet.And we examine correlation of EUS findings and postoperative pathology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of preoperative EUS evaluation of PDAC vascular invasion and postoperative pathological results
Key secondary outcomes
A) Ability to visualize various major blood vessels by EUS
B) Accuracy of staging in UICC TNM classification by EUS
C) Comparison of prognosis by presence or absence of vascular invasion in resected arteries
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) Pancreatic cancer patients who will under go surgery in our hospital.
2) Documented examination consent was obtained.
3) Age 20 years and over
4) After receiving sufficient explanation for the participation of this study, patients who obtained written agreement by the patient's free will with sufficient understanding
Key exclusion criteria
1) Patients diagnosed with distant metastasis before EUS
2) Patients with ECOG Performance status of 2 or more
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba university hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo, Chiba
TEL
043-222-7171
mikata@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsumi Yamato |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo, Chiba
TEL
043-222-7171
Homepage URL
aena2827@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
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
| 2017 | Year | 08 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | 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
We are planning to evaluate whether preoperative EUS evaluation of vascular invasion of pancreatic cancer is related with pathological result.
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032699
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