Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063378) titled 'The Detectability of Colorectal Adenomas of Narrow Band Imaging plus Texture and Color Enhancement Imaging mode: A Prospective Randomized Controlled Trial' on Oct. 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Colorectal polyp, Colorectal adenoma
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether the use of Narrow Band Imaging plus Texture and Color Enhancement Imaging (NBI+TXI) mode improves the adenoma detection rate (ADR) compared with White Light Imaging (WLI) during screening or surveillance colonoscopy.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - NBI+TXI group: A single whole-colorectal observation using NBI+TXI (Narrow Band Imaging plus Texture and Color Enhancement Imaging) mode during endoscope withdrawal from the cecum to the rectum on the day of the colonoscopy.
Interventions/Control_2 - WLI group: A single whole-colorectal observation using conventional WLI (White Light Imaging) during endoscope withdrawal from the cecum to the rectum on the day of the colonoscopy.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Patients scheduled for total colonoscopy for screening (including positive fecal occult blood test and investigation of abdominal symptoms) or post-polypectomy surveillance.
2. Patients aged 40 to 80 years at the time of informed consent.
3. Patients who have received sufficient explanation about the study and have voluntarily provided written informed consent.
Key exclusion criteria - 1. Patients with a history of colorectal resection (excluding appendectomy).
2. Patients with a history of inflammatory bowel disease.
3. Patients with a history of colorectal polyposis.
4. Patients with known existing colorectal polyps.
5. Pregnant or breastfeeding women.
6. Patients who have previously participated in this study.
7. Patients participating in other endoscopy-related interventional studies.
8. Patients deemed inappropriate for study participation by the investigator due to underlying diseases or other reasons.
Target Size - 380
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 10 Day
Date of IRB - 2026 Year 10 Month 20 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071632
Disclaimer: Curated by HT Syndication.