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Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03620695
Enrollment
60
Registered
2018-08-08
Start date
2018-06-01
Completion date
2018-10-31
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyps

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.

Interventions

None listed

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation5 months
Number of diagnostic agreement between pCLE with topical CV and histopathological results5 months
Number of participants with procedure-related adverse events5 months
Number of pCLE imaging failure with topical CV5 months

Countries

China

Contacts

Primary ContactYanqing Li, PhD. MD.
liyanqing@sdu.edu.cn18678827666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026