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.
Trials
; 24(1): 323, 2023 May 11.
Artículo
en Inglés
| MEDLINE | ID: covidwho-2314176
ABSTRACT
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:
Studydesign:
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. PRIMARYOUTCOMES:
Detection rates of gastric neoplasms and EGC. SECONDARYOUTCOMES:
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.Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Neoplasias Gástricas
/
COVID-19
Tipo de estudio:
Estudio de cohorte
/
Estudios diagnósticos
/
Estudio experimental
/
Estudio observacional
/
Estudio pronóstico
/
Ensayo controlado aleatorizado
Límite:
Adulto
/
Humanos
Idioma:
Inglés
Revista:
Trials
Asunto de la revista:
Medicina
/
Terapeutica
Año:
2023
Tipo del documento:
Artículo
País de afiliación:
S13063-023-07346-5
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