UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062027 |
|---|---|
| Receipt number | R000070953 |
| Scientific Title | A Prospective Observational Study on the Added Value of Red Dichromatic Imaging (RDI) with Indigo Carmine Chromoendoscopy for the Diagnosis of Colorectal Serrated Lesions: Evaluation of Visibility, Color Contrast, and Optimization of Crystal Violet Use |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/23 21:25:58 |
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Basic information
Public title
Study of RDI for Improved Diagnosis of Colorectal Serrated Lesions
Acronym
RDI-SSL Study
Scientific Title
A Prospective Observational Study on the Added Value of Red Dichromatic Imaging (RDI) with Indigo Carmine Chromoendoscopy for the Diagnosis of Colorectal Serrated Lesions: Evaluation of Visibility, Color Contrast, and Optimization of Crystal Violet Use
Scientific Title:Acronym
IC-RDI-SSL Study
Region
| Japan |
Condition
Condition
This applies to serrated lesions of the colon. Specifically, these include Sessile Serrated Lesions (SSL), hyperplastic polyps (HP), traditional serrated adenomas (TSA), and sessile serrated lesions with dysplasia (SSLD).
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify whether the combined observation method using indigo carmine and RDI improves the visibility of pit patterns in patients with serrated lesions of the colon (SSL, HP, TSA, or SSLD) compared to the use of indigo carmine alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the pit pattern visibility score (on a 1-5 ordinal scale) for the IC alone group and the IC plus RDI group.
Key secondary outcomes
1. CIEDE2000 Color Difference: Obtain the CIELAB values for the mucosa inside and around the pit in the captured endoscopic images, and calculate the color difference based on the CIEDE2000 formula.
2. CV Avoidance Rate: Calculated as the proportion of lesions classified as "Group B" (cases where the necessity of CV was uncertain based on IC observation alone) that were subsequently judged as "Group C" (cases where CV was not required) through combined IC+RDI observation.
3. Endoscopist Visibility Score: Unlike evaluations using a random image set, this analyzes visibility in actual clinical settings based on dynamic and multifaceted information.
4. Diagnostic Time: Measure the time (in seconds) from image presentation to the final response.
5. Diagnostic Accuracy (Exploratory): Using the pathological diagnosis as the gold standard, compare sensitivity, specificity, and accuracy.
6. Inter-rater Agreement Rate for Pit Pattern Interpretation: Calculated using the simple agreement rate and Fleiss' kappa.
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
1. Patients aged 20 years or older undergoing colonoscopy at our institution.
2. Patients in whom colonic serrated lesions (including SSL, TSA, HP, and SSLD) were identified during endoscopy and who underwent endoscopic resection of these lesions.
3. Patients who have not declined participation after disclosure of the study information through the opt-out process.
Key exclusion criteria
1. Lesions for which the pathological diagnosis of the resected specimen was other than a serrated lesion (SSL, HP, TSA, SSLD).
2. Patients who declined to participate in this study via the published opt-out document.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Yoshii |
Organization
Sapporo Medical University
Division name
Division of Gastroenterology and Hepatology
Zip code
060-8543
Address
291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo City
TEL
011-611-2111
shinjiyoshii@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Saito |
Organization
Sapporo Medical University
Division name
Division of Gastroenterology and Hepatology
Zip code
060-8543
Address
291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo City
TEL
011-611-2111
Homepage URL
mitsunobu.saitou0414@gmail.com
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Institutional Review Board for Clinical Research
Address
291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo City
Tel
011-611-2111
ji-rskk@ml.sapmed.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, single-center observational study. The study subjects will be patients who undergo colonoscopy at Sapporo Medical University Hospital between May 2026 and September 2027, meet the selection criteria, and do not decline participation based on the publicly available study information. When a colorectal serrated lesion (SSL, TSA, HP, or SSLD) is identified during colonoscopy, observation using Red Dichromatic Imaging (RDI) in combination with indigo carmine spraying (IC+RDI) will be performed following initial observation with indigo carmine spraying (IC). Images using both IC and IC+RDI will be acquired for the same lesion (target: 120 cases). The acquired images will be presented to evaluators (planned: 8 individuals) as a randomized set, and visibility scores (on a 5-point scale) will be assessed in a blinded manner. The primary endpoint is the difference in pit pattern visibility scores between IC and IC+RDI; secondary endpoints include color difference, visibility according to lesion characteristics, and the necessity of using Crystal Violet.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070953
