UMIN-CTR Clinical Trial

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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