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

Primary Purpose

Colorectal Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow band imaging
Chromoendoscopy
High definition white light endoscopy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

High definition white light endoscopy

Chromoendoscopy

Narrow band imaging

Arm Description

colonoscopy performed using high definition equipment

indigo carmine is sprayed on the colon mucosa during withdrawal phase

Narrow band imaging is used during withdrawal phase

Outcomes

Primary Outcome Measures

Adenomas per colonoscopy
total number of adenomas divided by total number of procedures

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2019
Last Updated
October 23, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04192929
Brief Title
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
Official Title
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI decision.
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High definition white light endoscopy
Arm Type
Placebo Comparator
Arm Description
colonoscopy performed using high definition equipment
Arm Title
Chromoendoscopy
Arm Type
Active Comparator
Arm Description
indigo carmine is sprayed on the colon mucosa during withdrawal phase
Arm Title
Narrow band imaging
Arm Type
Experimental
Arm Description
Narrow band imaging is used during withdrawal phase
Intervention Type
Device
Intervention Name(s)
Narrow band imaging
Intervention Description
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes
Intervention Type
Other
Intervention Name(s)
Chromoendoscopy
Intervention Description
Indigo carmine will be sprayed during withdrawal phase of colonoscopy
Intervention Type
Other
Intervention Name(s)
High definition white light endoscopy
Intervention Description
High definition equipment will be used to perform colonoscopy
Primary Outcome Measure Information:
Title
Adenomas per colonoscopy
Description
total number of adenomas divided by total number of procedures
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
total number of patients with adenomas divided by total number of procedures
Time Frame
during the procedure
Title
Sessile serrated polyps per colonoscopy
Description
total number of sessile serrated polyps divided by total number of procedures
Time Frame
during the procedure
Title
Sessile serrated polyp detection rate
Description
total number of patients with sessile serrated polyps divided by total number of procedures
Time Frame
during the procedure
Title
Withdrawal time
Description
Time from cecal intubation to end of the procedure
Time Frame
during the procedure
Title
Inspection time
Description
Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 40 years Referral for screening, surveillance or diagnostic colonoscopy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Rex, MD
Organizational Affiliation
IU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28842054
Citation
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.
Results Reference
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PubMed Identifier
27056645
Citation
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.
Results Reference
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PubMed Identifier
22258983
Citation
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:CD008361. doi: 10.1002/14651858.CD008361.pub2.
Results Reference
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PubMed Identifier
24751581
Citation
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.
Results Reference
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PubMed Identifier
30998991
Citation
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.
Results Reference
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Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

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