The effectiveness of a computer-aided system in improving the detection rate of gastric neoplasm and early gastric cancer: study protocol for a multi-centre, randomized controlled trial

Sep 24, 2026

Uploaded by Levi

Background outlines a multicentre randomized controlled trial protocol to test whether the computer-aided system ENDOANGEL-GC improves detection rates of gastric neoplasms and early gastric cancer during routine esophagogastroduodenoscopy (EGD). The protocol describes a prospective, single-blind, parallel-group design with stratified block randomisation by centre. The system will monitor blind spots, detect abnormalities, and identify neoplasms, while blinded assessors evaluate outcomes. Primary endpoints target detection rates of gastric neoplasms and early gastric cancer.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Abstract

Background

Methods

Study design

Settings

Participants and randomisation

Outcomes

Blinding

Sample size

Discussion

Introduction

Dong et al. Trials (2023) 24:323 [https://doi.org/10.1186/s13063-023-07346-5](https://doi.org/10.1186/s13063-023-07346-5) Trials STUDY PROTOCOL Open Access The effectiveness of a computer-aided system in improving the detection rate of gastric neoplasm and early gastric cancer: study protocol for a multi-centre, randomized controlled trial Zehua Dong1,2,3, Yijie Zhu1,2,3, Hongliu Du1,2,3, Junxiao Wang1,2,3, Xiaoquan Zeng1,2,3, Xiao Tao1,2,3, Ting Yang1,2,3, Jiamin Wang1,2,3, Mei Deng1,2,3, Jun Liu1,2,3, Lianlian Wu1,2,3*† and Honggang Yu1,2,3*† Abstract Background This protocol is for a multi-centre randomised controlled trial to determine whether the computeraided system ENDOANGEL-GC improves the detection rates of gastric neoplasms and early gastric cancer (EGC) in routine oesophagogastroduodenoscopy (EGD) . Methods Study design: Prospective, single-blind, parallel-group, multi-centre randomised controlled trial. Settings: The computer-aided system ENDOANGEL-GC was used to monitor blind spots, detect gastric abnormalities, and identify gastric neoplasms during EGD. Participants: Adults who underwent screening, diagnosis, or surveillance EGD. Randomisation groups: 1. Experiment group, EGD examinations with the assistance of the ENDOANGEL-GC; 2. Control group, EGD examinations without the assistance of the ENDOANGEL-GC. Randomisation: Block randomisation, stratified by centre. Primary outcomes: Detection rates of gastric neoplasms and EGC. Secondary outcomes: Detection rate of premalignant gastric lesions, biopsy rate, observation time, and number of blind spots on EGD. Blinding: Outcomes are undertaken by blinded assessors. Sample size: Based on the previously published findings and our pilot study, the detection rate of gastric neoplasms in the control group is estimated to be 2 . 5%, and that of the experimental group is expected to be 4 . 0% . With a †Lianlian Wu and Honggang Yu contributed equally to this work. *Correspondence: Lianlian Wu [wu_leanne@163.com](wu_leanne@163.com)[ ](wu_leanne@163.com)Honggang Yu[yuhonggang1968@163.com](yuhonggang1968@163.com) Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[. The Creative Commons Public Domain Dedication waiver (](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[http://creativeco](http://creativeco)[mmons.org/publicdomain/zero/1.0/](mmons.org/publicdomain/zero/1.0/)) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Dong et al. Trials (2023) 24:323 Page 2 of 9 two-sided α level of 0.05 and power of 80%, allowing for a 10% drop-out rate, the sample size is calculated as 4858. The detection rate of EGC in the control group is estimated to be 20%, and that of the experiment group is expected to be 35% . With a two-sided α level of 0.05 and power of 80%, a total of 270 cases of gastric cancer are needed. Assuming the proportion of gastric can

FAQs

What is the purpose of the ENDOANGEL-GC trial protocol?

To determine whether the computer-aided system ENDOANGEL-GC improves detection rates of gastric neoplasms and early gastric cancer during routine EGD.

How are participants assigned to the experiment and control groups?

Participants are randomized using block randomisation stratified by centre: the experiment group receives ENDOANGEL-GC assistance during EGD, while the control group has EGD without such assistance.

What are the primary outcomes of the trial?

The primary outcomes are the detection rates of gastric neoplasms and early gastric cancer (EGC).

How is blinding handled for outcome assessment?

Outcomes are assessed by blinded assessors to reduce assessment bias during the trial.

Sep 24, 2026

Uploaded by Levi