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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04192929
• Other study ID #: 1912241137
• Status: Withdrawn
• Phase: N/A
• Start date: September 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Neoplasms

Intervention

Device:
• Narrow band imaging
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes

Other:
• Chromoendoscopy
Indigo carmine will be sprayed during withdrawal phase of colonoscopy
• High definition white light endoscopy
High definition equipment will be used to perform colonoscopy

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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