Trials · 2023
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Dong Zehua, Zhu Yijie, Du Hongliu, Wang Junxiao, Zeng Xiaoquan, Tao Xiao, Yang Ting, Wang Jiamin, Deng Mei, Liu Jun, Wu Lianlian, Yu Honggang
Аннотация
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.
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.