Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

Colorectal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620695
• Other study ID #: 2018SDU-QILU-03
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 18678827666
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyps
• Polyps

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation		5 months
Primary	Number of diagnostic agreement between pCLE with topical CV and histopathological results		5 months
Primary	Number of participants with procedure-related adverse events		5 months
Primary	Number of pCLE imaging failure with topical CV		5 months