UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049272 |
|---|---|
| Receipt number | R000056103 |
| Scientific Title | Diagnostic performance and safety of Narrow Band Imaging magnification of colorectal tumors with acetic acid spraying |
| Date of disclosure of the study information | 2022/10/20 |
| Last modified on | 2022/10/20 10:36:54 |
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Basic information
Public title
Diagnostic performance and safety of Narrow Band Imaging magnification of colorectal tumors with acetic acid spraying
Acronym
Diagnostic performance and safety of Narrow Band Imaging magnification of colorectal tumors with acetic acid spraying
Scientific Title
Diagnostic performance and safety of Narrow Band Imaging magnification of colorectal tumors with acetic acid spraying
Scientific Title:Acronym
Diagnostic performance and safety of Narrow Band Imaging magnification of colorectal tumors with acetic acid spraying
Region
| Japan |
Condition
Condition
colorectal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the pit pattern diagnostic concordance and diagnostic performance of lesions that underwent ANBI-ME at appropriate concentration followed by crystal violet stained magnification (CV-ME) .
Basic objectives2
Others
Basic objectives -Others
To determine the appropriate concentration of acetic acid to be used for the acetic acid sprayed narrow band imaging magnification (ANBI-ME).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance of pit pattern diagnosis between NBI magnification under acetic acid spraying at appropriate concentrations and crystal violet staining magnification.
Key secondary outcomes
Differences in the degree of hyperperistalsis under various acetic acid concentrations
Frequency of posterior hemorrhage in cases of endoscopic resection after ANBI-ME
Accuracy of pit pattern in ANBI-ME and CV-ME
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone ANBI-ME for colorectal tumors and who have undergone endoscopic or surgical resection with pathologic results of adenoma or cancer
Key exclusion criteria
Persons with ulcerative colitis
Familial colorectal adenomatosis
Pregnant or possibly pregnant
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimizu |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Gastroenterology
Zip code
9830824
Address
Tsurugaya5-22-1, Miyagino ku, Sendai city, Miyagi
TEL
0220521111
takeshi.shimizu@openhp.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimizu |
Organization
Sendai city medical center Sendai Open Hospital
Division name
Gastroenterology
Zip code
9830824
Address
Tsurugaya5-22-1, Miyagino ku, Sendai city, Miyagi
TEL
0220521111
Homepage URL
takeshi.shimizu@openhp.or.jp
Sponsor or person
Institute
Sendai city medical center Sendai Open Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Sendai City Medical Center Sendai Open Hospital
Address
Tsurugaya5-22-1, Miyagino ku, Sendai city, Miyagi
Tel
0220521111
takeshi.shimizu@openhp.or.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
| 2022 | Year | 10 | Month | 20 | 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
330
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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospectively collect information based on electronic medical record information
Analyze information at the time of endoscopy, endoscopic images, and pathology information
Management information
Registered date
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056103
