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

NCT ID: NCT04192929

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-02-28

Brief Summary

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Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Randomization cards will be sealed and opened after the subject is deemed eligible for the study by the PI. This will be done in an area away from the subject but due to the nature of the study, PI can't be blinded.

Study Groups

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High definition white light endoscopy

colonoscopy performed using high definition equipment

Group Type PLACEBO_COMPARATOR

High definition white light endoscopy

Intervention Type OTHER

High definition equipment will be used to perform colonoscopy

Chromoendoscopy

indigo carmine is sprayed on the colon mucosa during withdrawal phase

Group Type ACTIVE_COMPARATOR

Chromoendoscopy

Intervention Type OTHER

Indigo carmine will be sprayed during withdrawal phase of colonoscopy

Narrow band imaging

Narrow band imaging is used during withdrawal phase

Group Type EXPERIMENTAL

Narrow band imaging

Intervention Type DEVICE

Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes

Interventions

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Narrow band imaging

Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes

Intervention Type DEVICE

Chromoendoscopy

Indigo carmine will be sprayed during withdrawal phase of colonoscopy

Intervention Type OTHER

High definition white light endoscopy

High definition equipment will be used to perform colonoscopy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Douglas K. Rex

Emeritus Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Rex, MD

Role: PRINCIPAL_INVESTIGATOR

IU

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Wieszczy P, Regula J, Kaminski MF. Adenoma detection rate and risk of colorectal cancer. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):441-446. doi: 10.1016/j.bpg.2017.07.002. Epub 2017 Jul 6.

Reference Type BACKGROUND
PMID: 28842054 (View on PubMed)

Brown SR, Baraza W, Din S, Riley S. Chromoscopy versus conventional endoscopy for the detection of polyps in the colon and rectum. Cochrane Database Syst Rev. 2016 Apr 7;4(4):CD006439. doi: 10.1002/14651858.CD006439.pub4.

Reference Type BACKGROUND
PMID: 27056645 (View on PubMed)

Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonoscopy for the detection of colorectal polyps. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008361. doi: 10.1002/14651858.CD008361.pub2.

Reference Type BACKGROUND
PMID: 22258983 (View on PubMed)

Leung WK, Lo OS, Liu KS, Tong T, But DY, Lam FY, Hsu AS, Wong SY, Seto WK, Hung IF, Law WL. Detection of colorectal adenoma by narrow band imaging (HQ190) vs. high-definition white light colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2014 Jun;109(6):855-63. doi: 10.1038/ajg.2014.83. Epub 2014 Apr 22.

Reference Type BACKGROUND
PMID: 24751581 (View on PubMed)

Atkinson NSS, Ket S, Bassett P, Aponte D, De Aguiar S, Gupta N, Horimatsu T, Ikematsu H, Inoue T, Kaltenbach T, Leung WK, Matsuda T, Paggi S, Radaelli F, Rastogi A, Rex DK, Sabbagh LC, Saito Y, Sano Y, Saracco GM, Saunders BP, Senore C, Soetikno R, Vemulapalli KC, Jairath V, East JE. Narrow-Band Imaging for Detection of Neoplasia at Colonoscopy: A Meta-analysis of Data From Individual Patients in Randomized Controlled Trials. Gastroenterology. 2019 Aug;157(2):462-471. doi: 10.1053/j.gastro.2019.04.014. Epub 2019 Apr 15.

Reference Type BACKGROUND
PMID: 30998991 (View on PubMed)

Other Identifiers

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1912241137

Identifier Type: -

Identifier Source: org_study_id

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