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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040285
Receipt No. R000045963
Scientific Title A prospective study to determine the appropriate number of to-and-fro movements per one pass of EUS-FNB for solid pancreatic lesions
Date of disclosure of the study information 2020/06/01
Last modified on 2020/10/31

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Basic information
Public title A prospective study to determine the appropriate number of to-and-fro movements per one pass of EUS-FNB for solid pancreatic lesions
Acronym A prospective study to determine the appropriate number of to-and-fro movements per one pass of EUS-FNB for solid pancreatic lesions
Scientific Title A prospective study to determine the appropriate number of to-and-fro movements per one pass of EUS-FNB for solid pancreatic lesions
Scientific Title:Acronym A prospective study to determine the appropriate number of to-and-fro movements per one pass of EUS-FNB for solid pancreatic lesions
Region
Japan

Condition
Condition solid pancreatic lesions
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the appropriate number of to-and-fro movements per one pass of EUS-FNB using Acquire22G for solid pancreatic lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of histological diagnosis by the number of to-and-fro movements.
Key secondary outcomes The total area of the specimen by the number of to-and-fro movements.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 The number of to-and-fro movements of EUS-FNB is 5 times in the first pass and 15 times in the second pass.
Interventions/Control_2 The number of to-and-fro movements of EUS-FNB is 15 times in the first pass and 5 times in the second pass.
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) Patients who need histopathological diagnosis for solid pancreatic lesions by EUS-FNB.
(2) Patients who provided written informed consent.
Key exclusion criteria (1) Patients in European Cooperative Oncology Group performance status 4.
(2) Patients with severe adverse events in other organs except those involving the original disease (American Society of Anesthesiologists classification greater than 3).
(3) Patients contraindicated for cessation of anticoagulant therapy.
(4) Pregnant patients or those suspected of being pregnant.
(5) Solid pancreatic lesions with definite diagnosis by another biopsy.
(6) Solid pancreatic lesions demonstrating difficulty in visualization on EUS.
(7) Patients who judged as inappropriate by attendant doctors.
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of gastroenterology
Zip code 466-8560
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2602
Email ishitaku@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kunio
Middle name
Last name Kataoka
Organization Nagoya University Graduate School of Medicine
Division name Department of gastroenterology
Zip code 466-8560
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2602
Homepage URL
Email kkataoka@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 Nagoya University Graduate School of Medicine
Address 65 tsurumai-cho, Showa-ku, Nagoya
Tel 052-744-2973
Email ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information
2020 Year 06 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 Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 08 Month 07 Day
Anticipated trial start date
2020 Year 10 Month 12 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 01 Day
Last modified on
2020 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045963

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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