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

Portal Hypertension Clinical Trial

Official title:

A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105): A Prospective, Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052892
• Other study ID #: CHESS2105
• Status: Not yet recruiting
• Start date: September 28, 2023
• Est. completion date: September 27, 2025

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Xiaolong Qi, MD
• Phone: +8618588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 27, 2025
• Est. primary completion date: September 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Diagnostic Test:
• Hepatic venous pressure gradient
All patients underwent measurement of HVPG under local anesthesia.

Locations

Country	Name	City	State
China	Shulan (Hangzhou) Hospital	Hangzhou
China	The First Hospital of Lanzhou University	Lanzhou
China	The Third People's Hospital of Taiyuan	Taiyuan

Sponsors (4)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province	LanZhou University, Shulan (Hangzhou) Hospital, The Third People's Hospital of Taiyuan

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of a new model based on spleen stiffness (kPa) measured by transient elastography for diagnosing portal hypertension.	In HVPG (mmHg) as reference method in evaluating portal pressure measured by intervention specialist , to develop a new model based on spleen stiffness (kPa) measured by transient elastography and evaluate the accuracy in diagnosing portal hypertension.	1 years
Secondary	Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis	To develop a novel model based on spleen stiffness (kPa) measured by transient elastography for predicting the incidence of liver decompensation in patients with compenstaed cirrhosis.	3 years