Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial.
Adenomas
Artificial Intelligence
Colonoscopy
Histology
Journal
Gastroenterology
ISSN: 1528-0012
Titre abrégé: Gastroenterology
Pays: United States
ID NLM: 0374630
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
18
02
2022
revised:
05
05
2022
accepted:
13
05
2022
pubmed:
2
6
2022
medline:
25
8
2022
entrez:
1
6
2022
Statut:
ppublish
Résumé
Colonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures. This randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥40 scheduled for screening or surveillance (≥3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat approach. Between January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified intention-to-treat analysis. APC increased significantly with use of the CADe device (standard vs CADe: 0.83 vs 1.05, P = .002; total number of adenomas, 562 vs 719). There was no decrease in THR with use of the CADe device (standard vs CADe: 71.7% vs 67.4%, P for noninferiority < .001; total number of non-neoplastic lesions, 284 vs 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065). For experienced endoscopists performing screening and surveillance colonoscopies in the United States, the CADe device statistically improved overall adenoma detection (APC) without a concomitant increase in resection of non-neoplastic lesions (THR). gov registration: NCT04754347.
Sections du résumé
BACKGROUND & AIMS
Colonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures.
METHODS
This randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥40 scheduled for screening or surveillance (≥3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat approach.
RESULTS
Between January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified intention-to-treat analysis. APC increased significantly with use of the CADe device (standard vs CADe: 0.83 vs 1.05, P = .002; total number of adenomas, 562 vs 719). There was no decrease in THR with use of the CADe device (standard vs CADe: 71.7% vs 67.4%, P for noninferiority < .001; total number of non-neoplastic lesions, 284 vs 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065).
CONCLUSIONS
For experienced endoscopists performing screening and surveillance colonoscopies in the United States, the CADe device statistically improved overall adenoma detection (APC) without a concomitant increase in resection of non-neoplastic lesions (THR).
CLINICALTRIALS
gov registration: NCT04754347.
Identifiants
pubmed: 35643173
pii: S0016-5085(22)00519-4
doi: 10.1053/j.gastro.2022.05.028
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04754347']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
732-741Investigateurs
Robert Thompson
(R)
Robert Chehade
(R)
Burr Loew
(B)
Jackie Downing
(J)
James Vermillion
(J)
Lawrence Borges
(L)
Ruma Rajbhandari
(R)
Theodore Schafer
(T)
Sahin Coban
(S)
James Richter
(J)
Peter Carolan
(P)
Francis Colizzo
(F)
Tiffany Jeong
(T)
Marisa DelSignore
(M)
Shreya Asher
(S)
Robert McCabe
(R)
Daniel Van Handel
(D)
Birtukan Cinnor
(B)
Benjamin Mitlyng
(B)
Cynthia Sherman
(C)
S David Feldshon
(SD)
Amy Lounsbury
(A)
Ana Thompson
(A)
Anusha Duggirala
(A)
Irena Davies
(I)
Christopher Huang
(C)
Charles Bliss
(C)
Arpan Mohanty
(A)
Oltion Sina
(O)
Jean Mendez
(J)
Allison Iwan
(A)
Jennifer Stromberg
(J)
Jonathan Ng
(J)
Lavi Erisson
(L)
Polina Golland
(P)
Daniel Wang
(D)
Evan Wlodkowski
(E)
Joseph Carlin
(J)
Perikumar Javia
(P)
Neelima Chavali
(N)
Austin Wang
(A)
Janine Little
(J)
Cara Hunsberger
(C)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.