UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045621 |
|---|---|
| Receipt number | R000052085 |
| Scientific Title | A single-center prospective study to evaluate the diagnostic performance of NBI magnification under acetic acid spraying for colorectal tumors |
| Date of disclosure of the study information | 2021/10/02 |
| Last modified on | 2024/10/02 09:28:53 |
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Basic information
Public title
Usefulness of acetic acid NBI magnification endoscopy for colorectal tumors
Acronym
Usefulness of acetic acid NBI magnification endoscopy for colorectal tumors(ANBI colon study)
Scientific Title
A single-center prospective study to evaluate the diagnostic performance of NBI magnification under acetic acid spraying for colorectal tumors
Scientific Title:Acronym
A single-center prospective study to evaluate the diagnostic performance of NBI magnified endoscopy under acetic acid spraying for colorectal tumors(ANBI colon study)
Region
| Japan |
Condition
Condition
Colorectal tumor diagnosed as JNET classification 2B by NBI magnified endoscopic observation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Equivalence of the diagnostic performance of NBI magnification under acetic acid spraying to that of crystal violet stained magnification endoscopy for the diagnosis of pit patterns
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter-methodological diagnostic agreement and inter-observer diagnostic agreement between NBI magnification endoscopic pit pattern diagnosis under acetic acid spraying and crystal violet stained magnification endoscopic pit pattern diagnosis of colorectal neoplasm
Key secondary outcomes
Results of pit pattern diagnosis by NBI under acetic acid spraying magnifying endoscopy and crystal violet-stained magnifying endoscopy , examination of findings specific to SM-d lesions as exploratory items, and adverse events.
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
a. Patients who are 18 years of age or older and who have received sufficient explanation and written consent for this study.
b. Patients who have a colorectal tumor requiring treatment by colonoscopy and diagnosed as JNET 2B or 3 by NBI magnification.
c. Patients who underwent NBI magnification under acetic acid spraying and crystal violet staining magnification of the region of interest, with the region diagnosed as JNET 2B or 3 as the region of interest, and both photographs were taken to show a well-focused pit pattern.
Key exclusion criteria
a. Recurrent lesions left over from endoscopic treatment
b. Patients who have received systemic chemotherapy within 6 months prior to endoscopic examination.
c. Patients with a history of radiation therapy to the abdominal pelvis.
d. Patients with a history of ulcerative colitis.
e. Patients who have been diagnosed with familial adenomatous polyposis.
f. Those who are pregnant or may become pregnant.
g. Those who are judged unsuitable by the doctor in charge.
Target sample size
300
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
Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
TEL
022-252-1111
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
Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
TEL
022-252-1111
Homepage URL
takeshi.shimizu@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center Sendai Open Hospital Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Sendai City Medical Center Sendai Open Hospital Department of Gastroenterology
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
Sendai City Medical Center Sendai Open Hospital
Address
Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
Tel
0222521111
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
| 2021 | Year | 10 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Non-interventional observational studies
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052085
