Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis

Liver Cirrhosis Clinical Trial

— NID-HRV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392503
• Other study ID #: KY-2023-10-59-1
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Beijing 302 Hospital
• Contact: Fu junliang, PHD
• Phone: 010-66933214
• Email: fjunliang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Varices
• Varicose Veins

Intervention

Diagnostic Test:
• different diagnostic models
the patients were screened by different diagnostic models

Locations

Country	Name	City	State
China	the Fifth Medical Center, Chinese PLA General Hospital	Beijing	Beijing

Sponsors (26)

Lead Sponsor

Collaborator

Beijing 302 Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;: — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endoscopy spared ratio	the percentage of patients spared with endoscopy	at end of the patient enrollment
Other	HRV missing ratio	the percentage of patients missed with high-risk varices	at end of the patient enrollment
Primary	diagnostic performance	sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models	at end of the patient enrollment