1. Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study.
- Author
-
Jiang X, Pan J, Xu Q, Song YH, Sun HH, Peng C, Qi XL, Qian YY, Zou WB, Yang Y, Jin SQ, Duan BS, Wu S, Chu Y, Xiao DH, Hu LJ, Cao JZ, Dai JF, Liu X, Xia T, Zhou W, Chen T, Zhou CH, Wu W, Liu SJ, Yang ZY, Wang F, Zhang L, Li CZ, Xu H, Wang JX, Wei B, Lin Y, Deng X, Qu LH, Shen YQ, Wang H, Huang YF, Bao HB, Zhang S, Li L, Shi YH, Wang XY, Zou DW, Wan XJ, Xu MD, Mao H, He CH, Li Z, Zuo XL, He SX, Xie XP, Liu J, Yang CQ, Spada C, Li ZS, and Liao Z
- Subjects
- Adult, Humans, Liver Cirrhosis complications, Prospective Studies, Capsule Endoscopy, Esophageal and Gastric Varices diagnosis, Esophageal and Gastric Varices etiology, Varicose Veins
- Abstract
Objective: To evaluate the diagnostic accuracy and safety of using magnetically guided capsule endoscopy with a detachable string (ds-MCE) for detecting and grading oesophagogastric varices in adults with cirrhosis., Design: Prospective multicentre diagnostic accuracy study., Setting: 14 medical centres in China., Participants: 607 adults (>18 years) with cirrhosis recruited between 7 January 2021 and 25 August 2022. Participants underwent ds-MCE (index test), followed by oesophagogastroduodenoscopy (OGD, reference test) within 48 hours. The participants were divided into development and validation cohorts in a ratio of 2:1., Main Outcome Measures: The primary outcomes were the sensitivity and specificity of ds-MCE in detecting oesophagogastric varices compared with OGD. Secondary outcomes included the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices and the diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices., Results: ds-MCE and OGD examinations were completed in 582 (95.9%) of the 607 participants. Using OGD as the reference standard, ds-MCE had a sensitivity of 97.5% (95% confidence interval 95.5% to 98.7%) and specificity of 97.8% (94.4% to 99.1%) for detecting oesophagogastric varices (both P<0.001 compared with a prespecified 85% threshold). When using the optimal 18% threshold for luminal circumference of the oesophagus derived from the development cohort (n=393), the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices in the validation cohort (n=189) were 95.8% (89.7% to 98.4%) and 94.7% (88.2% to 97.7%), respectively. The diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices was 96.3% (92.6% to 98.2%), 96.9% (95.2% to 98.0%), and 96.7% (95.0% to 97.9%), respectively. Two serious adverse events occurred with OGD but none with ds-MCE., Conclusion: The findings of this study suggest that ds-MCE is a highly accurate and safe diagnostic tool for detecting and grading oesophagogastric varices and is a promising alternative to OGD for screening and surveillance of oesophagogastric varices in patients with cirrhosis., Trial Registration: ClinicalTrials.gov NCT03748563., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the “Ten Thousand Plan”-National High-Level Talents Special Support Plan and Shanghai Municipal Hospital Emerging Frontier Technology Joint Project for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
- Full Text
- View/download PDF