NCT06392503

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 30, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

April 26, 2024

Last Update Submit

April 26, 2024

Conditions

VaricesLiver Cirrhosis

Keywords

diagnostic modelhigh risk varicesiLivTouch

Outcome Measures

Primary Outcomes (1)

  • diagnostic performance

    sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models

    at end of the patient enrollment

Other Outcomes (2)

  • Endoscopy spared ratio

    at end of the patient enrollment

  • HRV missing ratio

    at end of the patient enrollment

Study Arms (2)

retrospective cohort group

patients before the study started

Diagnostic Test: different diagnostic models

prospective cohort group

spatients after the study started

Diagnostic Test: different diagnostic models

Interventions

different diagnostic modelsDIAGNOSTIC_TEST

the patients were screened by different diagnostic models

prospective cohort groupretrospective cohort group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fifth Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 34713329BACKGROUND

  • 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.

    PMID: 26047908BACKGROUND

  • 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.

    PMID: 28696510BACKGROUND

  • 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.

    PMID: 33039403BACKGROUND

  • 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.

    PMID: 35120736BACKGROUND

  • 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.

    PMID: 36356684BACKGROUND

  • 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.

    PMID: 33939744BACKGROUND

  • 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.

    PMID: 25880975BACKGROUND

  • 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.

    PMID: 27788720BACKGROUND

  • 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.

    PMID: 29729368BACKGROUND

MeSH Terms

Conditions

Varicose VeinsLiver Cirrhosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fu junliang

    the Fifth Medical Center, Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu junliang, PHD

CONTACT

010-66933214fjunliang@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

November 30, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

April 30, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)