Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

November 4, 2024 updated by: Douglas K. Rex, Indiana University
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age ≥ 40 years
  2. Referral for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria:

  1. Inflammatory bowel disease
  2. History of colorectal cancer or colon resection
  3. Indication of positive FIT or cologuard
  4. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
  5. Patient with poor bowel preparation identified during insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: High definition white light endoscopy
colonoscopy performed using high definition equipment
Other: High definition white light endoscopy
High definition equipment will be used to perform colonoscopy
Active Comparator: Chromoendoscopy
indigo carmine is sprayed on the colon mucosa during withdrawal phase
Other: Chromoendoscopy
Indigo carmine will be sprayed during withdrawal phase of colonoscopy
Experimental: Narrow band imaging
Narrow band imaging is used during withdrawal phase
Device: Narrow band imaging
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenomas per colonoscopy
Time Frame: during the procedure
total number of adenomas divided by total number of procedures
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: during the procedure
total number of patients with adenomas divided by total number of procedures
during the procedure
Sessile serrated polyps per colonoscopy
Time Frame: during the procedure
total number of sessile serrated polyps divided by total number of procedures
during the procedure
Sessile serrated polyp detection rate
Time Frame: during the procedure
total number of patients with sessile serrated polyps divided by total number of procedures
during the procedure
Withdrawal time
Time Frame: during the procedure
Time from cecal intubation to end of the procedure
during the procedure
Inspection time
Time Frame: during the procedure
Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Douglas Rex, MD, IU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912241137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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