A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)

NCT ID: NCT05052892

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-28
• Study Completion Date: 2025-09-27

Brief Summary

Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Of them, liver stiffness measured by FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. Since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. Very recently, a novel spleen-dedicated stiffness measured by FibroScan was proposed. The prospective, multicenter study aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed cirrhosis.

Detailed Description

Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Of them, liver stiffness measured by FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. Since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. Very recently, a novel spleen-dedicated stiffness measured by FibroScan was proposed. The prospective, multicenter study (CHESS2105 leaded by The First Hospital of Lanzhou University and Shulan (Hangzhou) Hospital) aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed cirrhosis.

Conditions

Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Training cohort

Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.

Hepatic venous pressure gradient

Intervention Type: DIAGNOSTIC_TEST

All patients underwent measurement of HVPG under local anesthesia.

Validation cohort

Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.

Hepatic venous pressure gradient

Intervention Type: DIAGNOSTIC_TEST

All patients underwent measurement of HVPG under local anesthesia.

Interventions

Hepatic venous pressure gradient

All patients underwent measurement of HVPG under local anesthesia.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. age above or equal to 18-year-old

2. fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis

3. signed informed consent

Exclusion Criteria

1. Non-cirrhotic portal hypertension

2. Lactation or pregnancy

3. Suspicious or confirmed hepatocellular carcinoma

4. Asplenia or splenectomy

5. Incomplete clinical information

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Shulan (Hangzhou) Hospital

OTHER

Sponsor Role: collaborator

The Third People's Hospital of Taiyuan

OTHER

Sponsor Role: collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Qi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lanjuan Li, MD

Role: STUDY_CHAIR

Shulan (Hangzhou) Hospital

Xiaolong Qi, MD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Huadong Yan, MD

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Locations

Shulan (Hangzhou) Hospital

Hangzhou, , China

The First Hospital of Lanzhou University

Lanzhou, , China

The Third People's Hospital of Taiyuan

Taiyuan, , China

Countries

China

Central Contacts

Xiaolong Qi, MD

Role: CONTACT

qixiaolong@vip.163.com

+8618588602600

Ruiling He, MD

Role: CONTACT

1037039754@qq.com

+8618153674392

Facility Contacts

Huadong Yan

Role: primary

Liting Zhang

Role: primary

Ying Guo

Role: primary

References

Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.

Reference Type: BACKGROUND

PMID: 30215362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26047908 (View on PubMed)

Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.

Reference Type: BACKGROUND

PMID: 14767976 (View on PubMed)

Bureau C, Metivier S, Peron JM, Selves J, Robic MA, Gourraud PA, Rouquet O, Dupuis E, Alric L, Vinel JP. Transient elastography accurately predicts presence of significant portal hypertension in patients with chronic liver disease. Aliment Pharmacol Ther. 2008 Jun;27(12):1261-8. doi: 10.1111/j.1365-2036.2008.03701.x. Epub 2008 Apr 4.

Reference Type: BACKGROUND

PMID: 18397389 (View on PubMed)

Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27.

Reference Type: BACKGROUND

PMID: 22643348 (View on PubMed)

Vizzutti F, Arena U, Romanelli RG, Rega L, Foschi M, Colagrande S, Petrarca A, Moscarella S, Belli G, Zignego AL, Marra F, Laffi G, Pinzani M. Liver stiffness measurement predicts severe portal hypertension in patients with HCV-related cirrhosis. Hepatology. 2007 May;45(5):1290-7. doi: 10.1002/hep.21665.

Reference Type: BACKGROUND

PMID: 17464971 (View on PubMed)

Bastard C, Miette V, Cales P, Stefanescu H, Festi D, Sandrin L. A Novel FibroScan Examination Dedicated to Spleen Stiffness Measurement. Ultrasound Med Biol. 2018 Aug;44(8):1616-1626. doi: 10.1016/j.ultrasmedbio.2018.03.028. Epub 2018 May 3.

Reference Type: BACKGROUND

PMID: 29731186 (View on PubMed)

Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.

Reference Type: BACKGROUND

PMID: 31444849 (View on PubMed)

Other Identifiers

CHESS2105

Identifier Type: -

Identifier Source: org_study_id