Prospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Sep 16, 2023; 15(9): 564-573
Published online Sep 16, 2023. doi: 10.4253/wjge.v15.i9.564
Endoscopic Ruler for varix size measurement: A multicenter pilot study
Yi-Fei Huang, Sheng-Juan Hu, Yang Bu, Yi-Ling Li, Yan-Hong Deng, Jian-Ping Hu, Shao-Qi Yang, Qian Shen, Mark McAlindon, Rui-Chun Shi, Xiao-Qin Li, Tie-Ying Song, Hai-Long Qi, Tai-Wei Jiao, Meng-Yuan Liu, Fang He, Jun Zhu, Bin Ma, Xiao-Bin Yu, Jian-Yang Guo, Yue-Hua Yu, Hai-Jiang Yong, Wen-Tun Yao, Ting Ye, Hua Wang, Wen-Fu Dong, Jian-Guo Liu, Qiang Wei, Jing Tian, Xiao-Guo Li, Xavier Dray, Xiao-Long Qi
Yi-Fei Huang, Xiao-Guo Li, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou 730000, Gansu Province, China
Sheng-Juan Hu, Yang Bu, Yan-Hong Deng, Xiao-Bin Yu, Jian-Yang Guo, Department of Gastroenterology, People's Hospital of Ningxia Hui Autonomous Region, Ningxia Medical University Affiliated People's Hospital of Autonomous Region, Yinchuan 750000, Ningxia Hui Autonomous Region, China
Yi-Ling Li, Tai-Wei Jiao, Meng-Yuan Liu, Department of Gastroenterology, The First Affiliated Hospital of China Medical University, Shenyang 110000, Liaoning Province, China
Jian-Ping Hu, Bin Ma, Yue-Hua Yu, Wen-Tun Yao, Ting Ye, Department of Gastroenterology, Yinchuan First People's Hospital, Yinchuan 750000, Ningxia Hui Autonomous Region, China
Shao-Qi Yang, Fang He, Department of Gastroenterology, Ningxia Medical University General Hospital, Yinchuan 750000, Ningxia Hui Autonomous Region, China
Qian Shen, Department of Gastroenterology, Yinchuan Second People's Hospital, Yinchuan 750000, Ningxia Hui Autonomous Region, China
Mark McAlindon, Academic Department of Gastroenterology and Hepatology, Sheffield Teaching Hospitals NHS Trust, AL 35660, Sheffield, United Kingdom
Rui-Chun Shi, Hai-Jiang Yong, Department of Gastroenterology, Wuzhong People's Hospital, Wuzhong 751100, Ningxia Hui Autonomous Region, China
Xiao-Qin Li, Jun Zhu, Hua Wang, Wen-Fu Dong, Department of Gastroenterology, The Fifth People's Hospital of Ningxia Hui Autonomous Region, Shizuishan 753000, Ningxia Hui Autonomous Region, China
Tie-Ying Song, Department of Second Gastroenterology, The Sixth People’s Hospital of Shenyang, Shenyang 110000, Liaoning Province, China
Hai-Long Qi, Department of Gastroenterology, Shizuishan Second People's Hospital, Shizuishan 753000, Ningxia Hui Autonomous Region, China
Jian-Guo Liu, Qiang Wei, Jing Tian, Department of Gastroenterology, Zhongwei People's Hospital, Zhongwei 755000, Ningxia Hui Autonomous Region, China
Xavier Dray, Department of Hepato-Gastroenterology, ETIS, ENSEA, CNRS, Sorbonne Université & APHP, Hôpital Saint Antoine, Université Paris-Seine, Université de Cergy-Pontoise, Paris 75012, Sélectionner, France
Xiao-Long Qi, Center of Portal Hypertension, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing 210000, Jiangsu Province, China
Author contributions: Qi XL designed the research; Huang YF, Hu SJ, Bu Y, Li YL, Deng YH, Hu JP, Yang SQ, Shi RC, Li XQ, Song TY, Qi HL, Shen Q, Jiao TW, Liu MY, He F, Zhu J, Ma B, Yu XB, Guo JY, Yu YH, Yong HJ, Yao WT, Ye T, Wang H, Dong WF, Liu JG, Wei Q, Tian J and Li XG collected the data; Huang YF analyzed the data; Huang YF Wrote the first draft; Qi XL, Dray X and McAlindon M revised the paper; Huang YF, Hu SJ, Bu Y, Li YL, Deng YH, Hu JP, Yang SQ, and Shen Q contributed equally to this work.
Institutional review board statement: The study protocol was approved by the Institutional Review Board of principle research institutions.
Clinical trial registration statement: This study is registered at https://www.clinicaltrials.gov/. The registration identification number is NCT04639323.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: All authors declared no conflicts of interest related to this study.
Data sharing statement: Deidentified individual participant data will not be shared. Researchers can apply for data by submitting a proposal to the corresponding author.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Long Qi, MD, Professor, Center of Portal Hypertension, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, No.87 Dingjiaqiao, Gulou District Nanjing 210000, Jiangsu Province, China. qixiaolong@vip.163.com
Received: August 3, 2023
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
Processing time: 40 Days and 23.5 Hours
ARTICLE HIGHLIGHTS
Research background

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).

Research motivation

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.

Research objectives

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.

Research methods

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.

Research 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 (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.

Research conclusions

Endoscopic Ruler is feasible and safe for measuring the size of varices in patients with cirrhosis and portal hypertension.

Research perspectives

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.