UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040285 |
|---|---|
| Receipt number | 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 | 2023/05/04 13:50:31 |
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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
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
kkataoka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
85
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
Completed
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
| 2023 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045963
