UMIN-CTR Clinical Trial

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
Email	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
Email	takeshi.shimizu@openhp.or.jp

Sponsor
Institute	Sendai city medical center Sendai Open Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056103