Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps
- Conditions
- Colorectal Polyps
- Registration Number
- NCT03620695
- Lead Sponsor
- Shandong University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation 5 months Number of diagnostic agreement between pCLE with topical CV and histopathological results 5 months Number of participants with procedure-related adverse events 5 months Number of pCLE imaging failure with topical CV 5 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China