Clinical trial NCT04192929: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: 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

Primary outcomes:
measure: Adenomas per colonoscopy
timeFrame: during the procedure
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: during the procedure
measure: Sessile serrated polyps per colonoscopy
timeFrame: during the procedure
measure: Sessile serrated polyp detection rate
timeFrame: during the procedure
measure: Withdrawal time
timeFrame: during the procedure
measure: Inspection time
timeFrame: during the procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: IU
name: Douglas Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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(1):CD008361. doi: 10.1002/14651858.CD008361.pub2.
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.
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.