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

NCT04192929 | Withdrawn FDA Device

• 1 other identifier: 1912241137
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Adenomas per colonoscopy

  total number of adenomas divided by total number of procedures

  during the procedure

Secondary Outcomes (5)

• Adenoma detection rate

  during the procedure

• Sessile serrated polyps per colonoscopy

  during the procedure

• Sessile serrated polyp detection rate

  during the procedure

• Withdrawal time

  during the procedure

• Inspection time

  during the procedure

Study Arms (3)

High definition white light endoscopy

PLACEBO COMPARATOR

colonoscopy performed using high definition equipment

Other: High definition white light endoscopy

Chromoendoscopy

ACTIVE COMPARATOR

indigo carmine is sprayed on the colon mucosa during withdrawal phase

Other: Chromoendoscopy

Narrow band imaging

EXPERIMENTAL

Narrow band imaging is used during withdrawal phase

Device: Narrow band imaging

Interventions

Narrow band imaging DEVICE

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

Narrow band imaging

Chromoendoscopy OTHER

Indigo carmine will be sprayed during withdrawal phase of colonoscopy

Chromoendoscopy

High definition white light endoscopy OTHER

High definition equipment will be used to perform colonoscopy

High definition white light endoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Referral for screening, surveillance or diagnostic colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• 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.

  PMID: 28842054 BACKGROUND

• 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.

  PMID: 27056645 BACKGROUND

• 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.

  PMID: 22258983 BACKGROUND

• 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.

  PMID: 24751581 BACKGROUND

• 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.

  PMID: 30998991 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Douglas Rex, MD

  IU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: February 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)