Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis (NID-HRV)

Establishment of Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis Patients Based on iLivTouch

This is an observational ambispective cohort study to validate the Baveno VI guideline and develop a new diagnostic model to screen high-risk varices (HRV) of liver cirrhosis using iLivTouch.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Varices
• Intervention / Treatment: Diagnostic test: different diagnostic models

Detailed Description

Esophageal variceal bleeding is a common and fatal complication in patients with liver cirrhosis. The diagnosis of high-risk varices (HRV) traditionally depends on gastroscopy, which is expensive and poorly tolerated with patients. Baveno VI guideline has put forward a HRV screening model based on liver stiffness and platelet count. This is an observational ambispective cohort study. The retrospective cohort is derived from the previous records of the hospital information system, and the prospective cohort is enrolled prospectively at the local research center when participants meet the inclusion criteria. The purpose of this study is to establish a diagnostic model of HRV in patients with liver cirrhosis according to the liver stiffness value measured by iLivTouch and other laboratory indexes, so as to verify the applicability of Baveno VI standard under the condition of iLivTouch and establish a cutoff value that is more suitable for iLivTouch. In addition, this study will try to find some new indexes to further improve the diagnostic efficiency of HRV. The minimum enrolment period is anticipated to be 6 months per center and will be extended if necessary to reach the overall study target.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Fu junliang, PHD; Phone Number: 010-66933214; Email: fjunliang@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • the Fifth Medical Center, Chinese PLA General Hospital
      • Contact: Junliang Fu, MD; Phone Number: 010-66933214; Email: fjunliang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.

Description

Inclusion Criteria:

1. Age 18-75;
2. Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis;
3. The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months;

Exclusion Criteria:

1. the interval between esophagogastroduodenoscopy and iLivTouch is more than 3 months;
2. any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them;
3. currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs;
4. hepatocellular carcinoma;
5. after transjugular intrahepatic portosystemic shunt surgery;
6. after liver transplantation.
7. portal-spleen-mesenteric venous thrombosis;
8. patients with splenectomy;
9. BMI ≥ 30;
10. patients with acute active hepatitis or patients with cholestatic hepatitis;
11. IQR/median of liver stiffness measurement > 30%.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
retrospective cohort group; patients before the study started	Diagnostic test: different diagnostic models; the patients were screened by different diagnostic models
prospective cohort group; spatients after the study started	Diagnostic test: different diagnostic models; the patients were screened by different diagnostic models

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic performance	sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models	at end of the patient enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopy spared ratio	the percentage of patients spared with endoscopy	at end of the patient enrollment
HRV missing ratio	the percentage of patients missed with high-risk varices	at end of the patient enrollment

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Collaborators: LanZhou University; Shengjing Hospital; Qianfoshan Hospital; The Affiliated Hospital Of Guizhou Medical University; Second Affiliated Hospital of Xi'an Jiaotong University; First Hospital of China Medical University; Tianjin Third Central Hospital; Second Affiliated Hospital of Guangzhou Medical University; Chengdu Third People's Hospital; The Second Affiliated Hospital of Dalian Medical University; The Third People's Hospital of Taiyuan; The Fourth People's Hospital of Nanning; Yuncheng Central Hospital; the first affiliated hospital of Jiamusi university; The Second Norman Bethune Hospital of Jilin University; The First Hospital of Yulin; People's Hospital of Lixin County; The Fourth People's Hospital of Qinghai Provence; Central Hospital of Huludao; Jixi Infectious Diseases Hospital; Benxi Sixth People's Hospital; The First People's Hospital of Zigong City, Sichuan Province; Ruikang Affiliated Hospital of Guangxi University of Chinese Medicine; Guilin People's Hospital; Tianjin Binhai New Area Dagang Hospital
• Investigators: Principal Investigator: Fu junliang, the Fifth Medical Center, Chinese PLA General Hospital

Publications and helpful links

General Publications

• Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.
• de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
• Augustin S, Pons M, Maurice JB, Bureau C, Stefanescu H, Ney M, Blasco H, Procopet B, Tsochatzis E, Westbrook RH, Bosch J, Berzigotti A, Abraldes JG, Genesca J. Expanding the Baveno VI criteria for the screening of varices in patients with compensated advanced chronic liver disease. Hepatology. 2017 Dec;66(6):1980-1988. doi: 10.1002/hep.29363. Epub 2017 Oct 30.
• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30. Erratum In: J Hepatol. 2022 Apr 14;:
• Yan Y, Xing X, Wang X, Yang L. Liver stiffness by two-dimensional shear wave elastography for screening high-risk varices in patients with compensated advanced chronic liver disease. Eur Radiol. 2022 Mar;32(3):2078-2088. doi: 10.1007/s00330-021-08280-3. Epub 2021 Oct 29. Erratum In: Eur Radiol. 2024 Feb 1;:
• Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.
• Zhang X, Song J, Zhang Y, Wen B, Dai L, Xi R, Wu Q, Li Y, Luo X, Lan X, He Q, Luo W, Lai Q, Ji Y, Zhou L, Qi T, Liu M, Zhou F, Wen W, Li H, Liu Z, Chen Y, Zhu Y, Li J, Huang J, Cheng X, Tu M, Hou J, Wang H, Chen J. Baveno VII algorithm outperformed other models in ruling out high-risk varices in individuals with HBV-related cirrhosis. J Hepatol. 2023 Mar;78(3):574-583. doi: 10.1016/j.jhep.2022.10.030. Epub 2022 Nov 7.
• Ng YZ, Lai LL, Wong SW, Mohamad SY, Chuah KH, Chan WK. Attenuation parameter and liver stiffness measurement using FibroTouch vs Fibroscan in patients with chronic liver disease. PLoS One. 2021 May 3;16(5):e0250300. doi: 10.1371/journal.pone.0250300. eCollection 2021.
• Ou X, Wang X, Wu X, Kong Y, Duan W, Zhou J, Sun D, Wang Y, You H, Jia J. [Comparison of FibroTouch and FibroScan for the assessment of fibrosis in chronic hepatitis B patients]. Zhonghua Gan Zang Bing Za Zhi. 2015 Feb;23(2):103-6. doi: 10.3760/cma.j.issn.1007-3418.2015.02.006. Chinese.
• Zeng J, Sun WL, Chen GY, Pan Q, Yan SY, Sun C, Xu ZJ, Fan JG. [Efficiency of FibroScan and FibroTouch in liver stiffness measurement and fat quantification: a comparative analysis]. Zhonghua Gan Zang Bing Za Zhi. 2016 Sep 20;24(9):652-658. doi: 10.3760/cma.j.issn.1007-3418.2016.09.004. Chinese.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: iLivTouch; diagnostic model; high risk varices
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Varicose Veins
• Other Study ID Numbers: KY-2023-10-59-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After enrollment and data analysis, the study results will be submitted to peer-reviewed journals for publication. Personal information about potential and enrolled participants will be strictly confidential to the public before, during, and after the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No