Electronic Chromoendoscopy for Polyp Characterization

Colorectal Polyp Clinical Trial

Official title:

Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118856
• Other study ID #: TR-001
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: September 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients undergoing screening or surveillance colonoscopy

• written informed consent

Exclusion Criteria:

• inadequate bowel preparation

• polyposis syndromes

• history of colectomy

• use of anticoagulants

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

Diagnostic Test:
• Prediction of Histology
The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of predicting histology with EC	Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.	1 year