Actively Recruiting
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective, Randomized Controlled Study
Led by Shandong University · Updated on 2025-05-07
352
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods to improve the detection of colorectal adenomas during colonoscopy, which is important for preventing colorectal cancer. The study compares linked-color imaging (LCI), a new endoscopy technology that enhances lesion visibility using optimized colors, with indigo carmine chromoendoscopy, which involves spraying a dye on the colon lining. This prospective, randomized controlled trial aims to explore whether LCI can increase the adenoma detection rate compared to the dye spraying method. Participants who qualify will be randomly assigned to one of two groups after reaching the cecum during colonoscopy. One group will undergo colonoscopy using linked-color imaging to carefully observe the colon during withdrawal. The other group will receive indigo carmine dye spray during withdrawal for lesion detection. Any polyps or lesions found will be removed and examined pathologically. Data such as patient demographics, colonoscopy duration, and lesion details will be collected and analyzed. During the study, participants will undergo colonoscopy with either LCI or indigo carmine spraying, and lesions will be recorded and removed as needed. Researchers will measure the adenoma detection rate as the primary outcome, along with the detection rate of various lesion types. Patient information, colonoscopy data, and lesion characteristics will be documented. Statistical analysis will be conducted to compare outcomes. The study will follow participants from the start of the procedure to lesion assessment, aiming to provide evidence on the clinical value of LCI in colonoscopy.
CONDITIONS
Brief Title
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 85 years
- History of colorectal adenoma
- First-degree relatives with colorectal cancer or colorectal adenoma
- Presence of gastrointestinal symptoms such as abdominal pain, bloody stool, chronic diarrhea or constipation, unexplained anemia, or weight loss
- Positive Fecal Immunochemical Test
You will not qualify if you...
- Pregnancy
- Inflammatory bowel disease
- Familial adenomatosis polyposis
- Suspected colorectal cancer
- Intestinal obstruction
- Coagulopathy
- Intake of aspirin, clopidogrel, or other anticoagulants/antiplatelet drugs within 7 days
- Previous colorectal resection
- Failed cecal intubation
- Inadequate bowel preparation quality (BBPS ≤5)
- Refusal to participate or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo colonoscopy with either linked-color imaging endoscopy or chromoendoscopy with indigo carmine solution spray during the withdrawal process to detect colorectal adenomas and other lesions. Any detected lesions will be removed for pathological examination.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
R
Rui Ji MD PHD
R
Rui Ji MD PHD, +86-18560086103
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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