UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028840 |
|---|---|
| Receipt number | R000033008 |
| Scientific Title | Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET) |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2022/01/10 19:13:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Acronym
LCI for SNADET
Scientific Title
Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Scientific Title:Acronym
LCI for SNADET
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 endoscopy with LCI for SNADET
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The Visibility score of endoscopy with LCI for SNADET, and the relationship between this and the score of endoscopy with WLI, BLI, and BLI bright
Key secondary outcomes
The relationship between the Visibility score and patients characteristics (e.g. age, gender, and comorbidity), lesions characteristics (e.g. location, diameter, macroscopic appearance, and pathological findings) and objective assessment using graphics software
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 with sporadic SNADET
Key exclusion criteria
Patients with polyposis syndrome such as FAP, or evaluated incompetent by doctors in attendance
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
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
+81-43-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
+81-43-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-Ku, Chiba, Japan
Tel
0432227171
maruoka-cib@umin.ac.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691495/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691495/
Number of participants that the trial has enrolled
44
Results
For SNADETs of 44 patients, the visibility scores of LCI (3.53+-0.59) were significantly higher than those of WLI and BLI-b (2.66+-0.79 and 3.41+-0.64, respectively). The color differences between SNADETs and the adjacent normal duodenal mucosa in LCI mode (19.09+-8.33) were significantly
higher than those in WLI and BLI-b modes (8.67+-4.81 and 12.92+-7.95, respectively).
Results date posted
| 2022 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 44 patients and 44 lesions were evaluated. The mean age was 66.2+-9.5. Male were 32 and female were 12. The mean tumor size was 9.7+-5.9mm.
Participant flow
Between September 2017 and June 2019, consecutive patients diagnosed with SNADETs were enrolled in this study.
Adverse events
None
Outcome measures
Visibility score
Color difference
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy of endoscopy with LCI for SNADET will be analyzed.
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
