Published online Sep 16, 2023. doi: 10.4253/wjge.v15.i9.564
Peer-review started: August 3, 2023
First decision: August 15, 2023
Revised: August 18, 2023
Accepted: September 1, 2023
Article in press: September 1, 2023
Published online: September 16, 2023
Esophagogastroduodenoscopy (EGD) screening is usually performed by endoscopists with different levels of experience, and the they assess the locations and size of oesophageal varices (OV) according to the subjectivity. The recent Baveno VII consensus emphasized 2-grade classification system of Ovs followed from a management perspective, and the 2-grade classification system quantitatively classifies varix size into either small (< 5 mm) or large (≥ 5 mm).
The quantitative system is not widely used in clinical practice probably due to following limitations: Doubtful accuracy due to varix size assessment demanding high level of experience in specialized centers; lack of data on the interobserver agreement and reproducibility. We invented Endoscopic Ruler, a new endoscopic device to measure the size of varices in patients with cirrhosis and portal hypertension.
This study aims to assess the feasibility and safety of Endoscopic Ruler, and evaluate the agreement on identifying large OV between Endoscopic Ruler and the endoscopists, as well as the interobserver agreement on diagnosing large OV using Endoscopic Ruler.
We prospectively and consecutively enrolled patients with cirrhosis from 11 hospitals, all of whom got 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.
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 (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.
Endoscopic Ruler is feasible and safe for measuring the size of varices in patients with cirrhosis and portal hypertension.
Endoscopic Ruler weakened the value of an experienced operator and it might improve the management of patients with cirrhosis and portal hypertension in the non-tertiary hospitals without experienced endoscopist. Endoscopic Ruler might help to optimize the accuracy of the 2-grade classification system of OV followed from a management perspective. Endoscopic Ruler might normalize and promote development of novel non-invasive methods for OV screening.