NCT03620695

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

July 31, 2018

Last Update Submit

August 6, 2018

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients undergoing surveillance or screening colonoscopies will be recruited in this study at Qilu Hospital, Shandong University.

You may qualify if:

  • Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.

You may not qualify if:

  • Contraindications to CV (such as allergy);
  • Pregnancy or breastfeeding;
  • Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

  • Yanqing Li, PhD. MD.

    Department of Gastroenterology, Qilu Hospital, Shandong University

    STUDY DIRECTOR

Central Study Contacts

Yanqing Li, PhD. MD.

CONTACT

18678827666liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 8, 2018

Study Start

June 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

CN(1)