Clinical Trial: 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 (Japan)

Tokyo, June 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062027) titled 'Study of RDI for Improved Diagnosis of Colorectal Serrated Lesions' on June 24.

Study Type: Observational

Primary Sponsor: Institute - Sapporo Medical University

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 malignancy - Others Genomic information - NO

Objective: 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

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 Size - 120

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070953

Disclaimer: Curated by HT Syndication.