摘要
BACKGROUND We invented Endoscopic Ruler,a new endoscopic device to measure the size of varices in patients with cirrhosis and portal hypertension.AIM To assess the feasibility and safety of Endoscopic Ruler,and evaluate the agreement on identifying large oesophageal varices(OV)between Endoscopic Ruler and the endoscopists,as well as the interobserver agreement on diagnosing large OV using Endoscopic Ruler.METHODS We prospectively and consecutively enrolled patients with cirrhosis from 11 hospitals,all of whom got esophagogastroduodenoscopy(EGD)with Endoscopic Ruler.The primary study outcome was a successful measurement of the size of varices using Endoscopic Ruler.The secondary outcomes included adverse events,operation time,the agreement of identifying large OV between the objective measurement of Endoscopic Ruler and the empirical reading of endoscopists,together with the interobserver agreement on diagnosing large OV by Endoscopic Ruler.RESULTS From November 2020 to April 2022,a total of 120 eligible patients with cirrhosis were recruited and all of them underwent EGD examinations with Endoscopic Ruler successfully without any adverse event.The median operation time of Endoscopic Ruler was 3.00 min[interquartile range(IQR):3.00 min].The kappa value between Endoscopic Ruler and the endoscopists while detecting large OV was 0.52,demonstrating a moderate agreement.The kappa value for diagnosing large OV using Endoscopic Ruler among the six independent observers was 0.77,demonstrating a substantial agreement.CONCLUSION The data demonstrates that Endoscopic Ruler is feasible and safe for measuring the size of varices in patients with cirrhosis and portal hypertension.Endoscopic Ruler is potential to promote the clinical practice of the two-grade classification system of OV.
基金
This study is registered at https://www.clinicaltrials.gov/.The registration identification number is NCT04639323.
