计算机辅助系统提高胃肿瘤和早期胃癌检出率的效果：多中心、随机对照试验研究方案。

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.

机构信息

Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.

Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China.

出版信息

Trials. 2023 May 11;24(1):323. doi: 10.1186/s13063-023-07346-5.

BACKGROUND

This protocol is for a multi-centre randomised controlled trial to determine whether the computer-aided 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 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 cancer to be 1% in patients undergoing EGD and allowing for a 10% dropout rate, the sample size is calculated as 30,000. Considering the larger sample size calculated from the two primary endpoints, the required sample size is determined to be 30,000.

DISCUSSION

The results of this trial will help determine the effectiveness of the ENDOANGEL-GC in clinical settings.

TRIAL REGISTRATION

ChiCTR (Chinese Clinical Trial Registry), ChiCTR2100054449, registered 17 December 2021.

背景

本方案为一项多中心随机对照试验，旨在确定计算机辅助系统 ENDOANGEL-GC 是否能提高常规食管胃十二指肠镜（EGD）检查中胃肿瘤和早期胃癌（EGC）的检出率。

方法

研究设计：前瞻性、单盲、平行组、多中心随机对照试验。

设置

在 EGD 中使用计算机辅助系统 ENDOANGEL-GC 监测盲区、检测胃异常和识别胃肿瘤。

参与者

接受筛查、诊断或监测 EGD 的成年人。随机分组：1. 实验组，在 ENDOANGEL-GC 的辅助下进行 EGD 检查；2. 对照组，不使用 ENDOANGEL-GC 进行 EGD 检查。

随机化

区组随机化，按中心分层。

主要结局

胃肿瘤和 EGC 的检出率。

次要结局

癌前胃病变的检出率、活检率、观察时间和 EGD 上的盲区数量。

盲法

结局由盲法评估者进行评估。

样本量

根据先前发表的研究结果和我们的预试验，对照组胃肿瘤的检出率预计为 2.5%，实验组预计为 4.0%。双侧 α 水平为 0.05，效能为 80%，允许 10%的失访率，样本量计算为 4858。对照组 EGC 的检出率预计为 20%，实验组预计为 35%。双侧 α 水平为 0.05，效能为 80%，共需 270 例胃癌。假设 EGD 患者中胃癌的比例为 1%，并允许 10%的失访率，样本量计算为 30000。考虑到两个主要终点计算出的较大样本量，确定所需样本量为 30000。

讨论

本试验的结果将有助于确定 ENDOANGEL-GC 在临床环境中的有效性。

试验注册

ChiCTR（中国临床试验注册中心），ChiCTR2100054449，于 2021 年 12 月 17 日注册。