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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031968
Receipt No. 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 2018/05/16

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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
Middle name
Last name Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Email sagami1985@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Homepage URL
Email sagami1985@yahoo.co.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

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
Email

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
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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