UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031968 |
|---|---|
| Receipt number | R000036469 |
| Scientific Title | Usefullness of conbined use endoscopic ultrasound fine needle aspiration and biopsy (EUS-FNAB), and serial pancreatic juice aspiration cytological examination (SPACE)for preoperative histological diagnosis of pancreatic cancer. |
| Date of disclosure of the study information | 2018/03/29 |
| Last modified on | 2023/10/02 09:13:05 |
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Basic information
Public title
Usefullness of conbined use endoscopic ultrasound fine needle aspiration and biopsy (EUS-FNAB), and serial pancreatic juice aspiration cytological examination (SPACE)for preoperative histological diagnosis of pancreatic cancer.
Acronym
EUS-FNAB vs. pancreatic juice cytology for histological diagnosis of pancreatic cancer.
Scientific Title
Usefullness of conbined use endoscopic ultrasound fine needle aspiration and biopsy (EUS-FNAB), and serial pancreatic juice aspiration cytological examination (SPACE)for preoperative histological diagnosis of pancreatic cancer.
Scientific Title:Acronym
EUS-FNAB vs. pancreatic juice cytology for histological diagnosis of pancreatic cancer.
Region
| Japan |
Condition
Condition
Operable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preoperative histological diagnostic ability EUS-FNAB and SPACE, and additional effect of both for the same pancreatic cancer.
To evaluate of complication rate when EUS-FNAB and SPACE are simultaneously performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological confirmation of pancreatic cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform EUS-FANB for tumor of pancreatic head, when histologically confirmed diagnosis can not be made, perform pancreatic juice cytology.
Interventions/Control_2
Perform EUS-FANB or PJC randomly for tumor of pancreatic body or tail,when histologically confirmed diagnosis can not be made, perform the other examination.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Strongly suspected of pancreatic malignant tumor with various modalities.
Patients with operable general condition.
Key exclusion criteria
When informed consent can not be obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
New Tokyo 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
New Tokyo Hospital
Address
1271 Wanagaya, Matsudo, Chiba, Japan
Tel
0477118700
sagami1985@yahoo.co.jp
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
| 2018 | Year | 03 | Month | 29 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036469
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