NCT02217449

Brief Summary

To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

August 8, 2014

Last Update Submit

December 10, 2020

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HD

Prediction of histology

Other: Prediction of histology

Virtual Chromoendoscopy

Prediction of histology

Other: Prediction of histology

Interventions

Prediction of histologyOTHER
HDVirtual Chromoendoscopy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing screeining or surveillance colonoscopy

You may qualify if:

  • Written informed consent
  • Screening or surveillance colonoscopy

You may not qualify if:

  • history of inflammatory bowel disease
  • poor bowel preparation
  • colectomy
  • anticoagulation
  • polyposis syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

Location

Related Publications (1)

  • Rath T, Tontini GE, Nagel A, Vieth M, Zopf S, Gunther C, Hoffman A, Neurath MF, Neumann H. High-definition endoscopy with digital chromoendoscopy for histologic prediction of distal colorectal polyps. BMC Gastroenterol. 2015 Oct 22;15:145. doi: 10.1186/s12876-015-0374-3.

    PMID: 26493200DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 15, 2014

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

DE(1)