Trials / Recruiting
RecruitingNCT06961149
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- Sponsor
- Shandong University · Academic / Other
- Sex
- All
- Age
- 45 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, participants will be recruited to the study and randomized to one of two groups. Group allocation was revealed to endoscopists upon confirmation of cecal intubation. participants in Group A (treatment group) will undergo colonoscopy with LCI. participants in Group B (control group) will undergo spraying indigo carmine solution during withdrawal process. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the participants' general information (such as gender, age, symptoms, body mass index，etc.), colonoscopy data (such as duration etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using Independent Samples t test. Categorical variables were expressed as frequency counts (percentages) and analyzed using Pearson's chi-square test or the Fisher exact test. Statistical analyses were performed using SPSS 27.0. Statistical significance was defined as P \< 0.05.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Chromoendoscopy with indigo carmine solution spray | Patients will undergo chromoendoscopy with spraying indigo carmine. |
| PROCEDURE | Linked-color imaging endoscopy | Patients will undergo Linked-color imaging endoscopy. |
Timeline
- Start date
- 2025-04-08
- Primary completion
- 2026-01-31
- Completion
- 2026-04-01
- First posted
- 2025-05-07
- Last updated
- 2025-05-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06961149. Inclusion in this directory is not an endorsement.