VaricesNID-HRVNCT06392503
Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis
An observational study of Varices and Liver Cirrhosis, run by Beijing 302 Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Varices, Liver Cirrhosis
- What is being tested?
- different diagnostic models
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.
Who may be able to join
- 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;
Who cannot join
- 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.
Show all 11Show fewer
- 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%.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Junliang Fu, MD, 010-66933214, fjunliang@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Varices, Liver Cirrhosis
- Being tested
- different diagnostic models
- Keywords
- diagnostic model, high risk varices, iLivTouch
- Medical subject headings
- Varicose Veins, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different diagnostic modelsDiagnostic test
the patients were screened by different diagnostic models
| Study group | Role | What they receive |
|---|---|---|
| retrospective cohort group | patients before the study started Receives: Diagnostic Test: different diagnostic models | |
| prospective cohort group | spatients after the study started Receives: Diagnostic Test: different diagnostic models |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance
sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models
Measured: at end of the patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, First Hospital of China Medical University, The Second Affiliated Hospital of Dalian Medical University, Second Hospital of Jilin University, Shengjing Hospital, The Affiliated Hospital Of Guizhou Medical University, The First Hospital of Yulin, LanZhou University, Chengdu Third People's Hospital, Tianjin Third Central Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, People's Hospital of Lixin County, The Fourth People's Hospital of Qinghai Province, The Fourth People's Hospital of Nanning, The Third People's Hospital of Taiyuan, Central Hospital of Huludao, Jixi Infectious Diseases Hospital, First Affiliated Hospital of Jiamusi University, Benxi Sixth People's Hospital, Yuncheng Central Hospital, The First People's Hospital of Zigong City, Sichuan Province, Second Affiliated Hospital of Guangzhou Medical University, Ruikang Affiliated Hospital of Guangxi University of Chinese Medicine, Guilin People's Hospital, Tianjin Binhai New Area Dagang Hospital
- Responsible party
- Sponsor
- Investigators
- Fu junliang, Principal investigator, the Fifth Medical Center, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392503
- Sponsor's protocol ID
- KY-2023-10-59-1
- Acronym
- NID-HRV
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34713329de 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.
PubMed 26047908Augustin 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.
PubMed 28696510Wang 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.
PubMed 33039403de 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.
PubMed 35120736Zhang 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.
PubMed 36356684Ng 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.
PubMed 33939744Ou 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.
PubMed 25880975Zeng 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.
PubMed 27788720Colecchia 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.
PubMed 29729368
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis Patients Based on iLivTouch
- ClinicalTrials.gov ID
- NCT06392503
- Acronym / sponsor ID
- NID-HRV / KY-2023-10-59-1
- Conditions
- Varices, Liver Cirrhosis
- Keywords
- diagnostic model, high risk varices, iLivTouch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, First Hospital of China Medical University, The Second Affiliated Hospital of Dalian Medical University, Second Hospital of Jilin University, Shengjing Hospital, The Affiliated Hospital Of Guizhou Medical University, The First Hospital of Yulin, LanZhou University, Chengdu Third People's Hospital, Tianjin Third Central Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, People's Hospital of Lixin County, The Fourth People's Hospital of Qinghai Province, The Fourth People's Hospital of Nanning, The Third People's Hospital of Taiyuan, Central Hospital of Huludao, Jixi Infectious Diseases Hospital, First Affiliated Hospital of Jiamusi University, Benxi Sixth People's Hospital, Yuncheng Central Hospital, The First People's Hospital of Zigong City, Sichuan Province, Second Affiliated Hospital of Guangzhou Medical University, Ruikang Affiliated Hospital of Guangxi University of Chinese Medicine, Guilin People's Hospital, Tianjin Binhai New Area Dagang Hospital
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort group | – | Diagnostic Test: different diagnostic modelspatients before the study started |
| prospective cohort group | – | Diagnostic Test: different diagnostic modelsspatients after the study started |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different diagnostic modelsthe patients were screened by different diagnostic models | Diagnostic test | prospective cohort group, retrospective cohort group |
Primary outcome
diagnostic performance
Time frame: at end of the patient enrollment
sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 34713329Yan 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.
- Background: PubMed 26047908de 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.
- Background: PubMed 28696510Augustin 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.
- Background: PubMed 33039403Wang 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.
- Background: PubMed 35120736de 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.
- Background: PubMed 36356684Zhang 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.
- Background: PubMed 33939744Ng 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.
- Background: PubMed 25880975Ou 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.
- Background: PubMed 27788720Zeng 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.
- Background: PubMed 29729368Colecchia 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu junliang principal investigator
the Fifth Medical Center, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varices and Liver Cirrhosis, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu junliang, PHD (010-66933214, fjunliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance (time frame: at end of the patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392503, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.