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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044023
Receipt No. R000049827
Scientific Title The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer
Date of disclosure of the study information 2021/05/01
Last modified on 2021/05/14

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Basic information
Public title The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer
Acronym The usefulness of the SOSE of the EUS-TA for the preoperative diagnosis in patients with PC
Scientific Title The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer
Scientific Title:Acronym The usefulness of the SOSE of the EUS-TA for the preoperative diagnosis in patients with PC
Region
Japan

Condition
Condition resectable pancreatic cancer or borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy obtained by the minimum number of punctures required for EUS-guided tissue acquisition with stereomicroscopic on-site evaluation in patients with resectable or borderline resectable pancreatic cancer, in multicenter prospective trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic accuracy of the EUS-TA with SOSE
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 procedure of the EUS-TA with SOSE
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 tumor which are required EUS-TA for pathological diagnosis
2) patients whom suspected resectable or borderline resectable pancreatic cancer
3) adequate organ functions
4) providing written informed consent, and age =or >20
Key exclusion criteria 1) patients in which iodine-containing contrast agent cannot be used due to drug allergies or renal dysfunction
Target sample size 47

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL +81-42-778-8111
Email kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL +81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization self funding
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 Institutional Ethics Committee of Kitasato University Hospital
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel +81-42-778-7756
Email rinri@med.kitasato-u.ac.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 Kitasato University Hospital, Isehara Kyodo Hospital, JCHO Sagamino Hospital

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 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
2021 Year 03 Month 01 Day
Date of IRB
2021 Year 05 Month 14 Day
Anticipated trial start date
2021 Year 05 Month 14 Day
Last follow-up date
2026 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 23 Day
Last modified on
2021 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049827

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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