Comparing two methods for detecting colorectal polyps during colonoscopy
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study
This study is testing which method, Linked-color imaging or indigo carmine chromoendoscopy, is better at finding colorectal polyps during colonoscopy for people aged 45 to 85 who have had polyps before or have related symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06961149 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Linked-color imaging (LCI) versus indigo carmine chromoendoscopy in detecting colorectal adenomas during colonoscopy. Participants aged 45 to 85 with a history of colorectal adenoma or related gastrointestinal symptoms will be randomly assigned to one of two groups: one receiving LCI and the other undergoing indigo carmine spraying. The study will analyze various data points, including lesion characteristics and colonoscopy duration, to determine which method yields a higher adenoma detection rate. Statistical analyses will be performed to assess the significance of the findings.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 85 with a history of colorectal adenoma or related gastrointestinal symptoms.
Not a fit: Patients with conditions such as inflammatory bowel disease, suspected colorectal cancer, or those on anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection rates of colorectal adenomas, potentially reducing the risk of colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with image-enhanced endoscopy techniques, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Rui Ji MD PHD
- Email: qljirui@email.sdu.edu.cn
- Phone: +86-18560086103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.