Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Polyps
- Sponsor
- Shandong University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
- Last Updated
- 7 years ago
Overview
Brief Summary
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.
Investigators
Yanqing Li
Vice president of Qilu Hospital
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.
Exclusion Criteria
- •Contraindications to CV (such as allergy);
- •Pregnancy or breastfeeding;
- •Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
Time Frame: 5 months
Number of diagnostic agreement between pCLE with topical CV and histopathological results
Time Frame: 5 months
Number of participants with procedure-related adverse events
Time Frame: 5 months
Number of pCLE imaging failure with topical CV
Time Frame: 5 months