Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

NCT ID: NCT03620695

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Colorectal Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, PhD. MD.

Role: CONTACT

18678827666

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2018SDU-QILU-03

Identifier Type: -

Identifier Source: org_study_id

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