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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014682
Receipt No. R000017039
Scientific Title Probed-based confocal laser endomicroscopy imaging versus conventional endoscopy for differential diagnosis of duodenal neoplastic lesions: a prospective study
Date of disclosure of the study information 2014/07/28
Last modified on 2015/07/29

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Basic information
Public title Probed-based confocal laser endomicroscopy imaging versus conventional endoscopy for differential diagnosis of duodenal neoplastic lesions: a prospective study
Acronym Duo neoplasia study
Scientific Title Probed-based confocal laser endomicroscopy imaging versus conventional endoscopy for differential diagnosis of duodenal neoplastic lesions: a prospective study
Scientific Title:Acronym Duo neoplasia study
Region
Japan

Condition
Condition duodenal neoplastic lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accuracy of confocal laser endomicroscopy imaging and conventional endoscopy on the diagnosis of duodenal neoplastic lesions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accuracy of diagnosis
Key secondary outcomes finding of confocal laser endomicroscopy imaging

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Patients with duodenal neoplastic lesions undergo conventional endoscopy and confocal laser endomicroscopy imaging for diagnosis,then they will be histologically evaluated.
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 The case with duodenal neoplastic lesions in the patients who undergo esophagogastroduodenoscopy at the NTT Medical Centor Tokyo
Key exclusion criteria No other serious complications, and use of no medications that might interfere with obtaining a biopsy specimen.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nonaka Kouichi
Organization NTT Medical Centor Tokyo
Division name Department of gastroenterology
Zip code
Address 5-9-22,Higashi-Gotanda,Shinagawa-ku,Tokyo
TEL 03-3448-6111
Email nonaka513@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nonaka Kouichi
Organization NTT Medical Centor Tokyo
Division name Department of gastroenterology
Zip code
Address 5-9-22,Higashi-Gotanda,Shinagawa-ku,Tokyo
TEL 03-3448-6111
Homepage URL
Email nonaka513@gmail.com

Sponsor
Institute NTT Medical Centor Tokyo
Institute
Department

Funding Source
Organization none
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 NTT東日本関東病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 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: A simple classification system for in vivo diagnosis of duodenal epithelial tumors by using CLE was developed and validated. The sensitivity, specificity, and accuracy were 90%, 100%, and 97%, respectively. Positive and negative predictive values were calculated as 100% and 96%. The kappa coefficient representing consistency was 1 between observers and within each observer. 


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
2014 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017039

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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