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Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

S

Shandong University

Status

Unknown

Conditions

Colorectal Polyps

Study type

Observational

Funder types

Other

Identifiers

NCT03620695
2018SDU-QILU-03

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Yanqing Li, PhD. MD.

Data sourced from clinicaltrials.gov

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