Virtual Chromoendoscopy for Distal Polyps

Colorectal Polyps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217449
• Other study ID #: HN-0010
• Status: Completed
• Start date: January 2011

Study information

• Verified date: December 2020
• 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 with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Screening or surveillance colonoscopy

Exclusion Criteria:

• history of inflammatory bowel disease

• poor bowel preparation

• colectomy

• anticoagulation

• polyposis syndrome

Related Conditions & MeSH terms

• Colorectal Polyps
• Polyps

Intervention

Other:
• Prediction of histology

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	Effectivity of virtual chromoendoscopy	Upon visualization of a polyp in white-light, the location and size (as compared to open biopsy forceps or snare) are noted. Afterwards, virtual chromoendoscopy is used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist makes 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, the endoscopist is assigning a level of confidence (high or low) to each real time prediction. Afterwards, all polyps are resected using standard techniques and processed for pathological evaluation. Each polyp is assessed by an experienced GI pathologist blinded to the real time prediction of polyp histology. Finally, real time and histological results are compared.	3 years