NCT06961149 Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate
| NCT ID | NCT06961149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shandong University |
| Condition | Colonic Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 352 participants in total. It began in 2025-04-08 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Linked-color imaging (LCI) is a newly developed image-enhanced endoscopy technology. It relies on wave length optimization of three colors (red, green, and blue) to make the lesions appear fuller. LCI improves the visibility of colorectal adenomas and polyps and may increase the detection rate of lesions. In order to explore the clinical application value of Linked-color imaging endoscopy, we performed a prospective, randomized controlled trial to compare adenoma detection rate of Linked-color imaging endoscopy and indigo carmine chromoendoscopy.
Eligibility Criteria
Inclusion Criteria: 1. Age between 45 and 85 years 2. Patients with a history of colorectal adenoma 3. Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma 4. Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss; 5. Patients with positive Fecal Immunochemical Test Exclusion Criteria: 1. Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy 2. Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days 3. Patents previous colorectal resection 4. Patients with failed cecal intubation 5. Patients with inadequate bowel preparation quality (BBPS≤5) 6. Patients who refuse to participate or to provide informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06961149 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 85 Years, studying Colonic Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06961149 currently recruiting?
Yes, NCT06961149 is actively recruiting participants. Contact the research team at qljirui@email.sdu.edu.cn for enrollment information.
Where is the NCT06961149 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06961149 clinical trial?
NCT06961149 is sponsored by Shandong University. The trial plans to enroll 352 participants.