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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016815
Receipt No. R000019523
Scientific Title Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Date of disclosure of the study information 2015/03/17
Last modified on 2019/02/11

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Basic information
Public title Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Acronym Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma
Scientific Title Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Scientific Title:Acronym Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma
Region
Japan

Condition
Condition Sporadic nonampullary duodenal adenoma/carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The accuracy of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma)
Key secondary outcomes The sensitivity, specificity, positive predictive value, and negative predictive value of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma) and the relationship between these and patients background or lesions information

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent endoscopic resection of nonampurally duodenal lesions and confirmed diagnosis of adenoma/carcinoma with pathological diagnosis
Key exclusion criteria Patients with polyposis syndrome or evaluated incompetent by doctors in attendance
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Maruoka
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Homepage URL
Email maruoka-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
Address
Tel
Email

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 千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://journals.sagepub.com/doi/pdf/10.1177/2050640614548980
Number of participants that the trial has enrolled
Results 
CV-ME does not have additional diagnostic value compared with NBI-ME in the diagnosis of sporadic nonampullary duodenal adenoma/carcinoma.
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
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We perform a retrospective study for magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma.

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019523

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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