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

NCT05052892 | Unknown

• 1 other identifier: CHESS2105
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Portal Hypertension

Keywords

cirrhosis; spleen stiffness; portal hypertension; hepatic venous pressure gradient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis

  3 years

Study Arms (2)

Training cohort

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

Diagnostic Test: Hepatic venous pressure gradient

Validation cohort

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

Diagnostic Test: Hepatic venous pressure gradient

Interventions

Hepatic venous pressure gradient DIAGNOSTIC_TEST

All patients underwent measurement of HVPG under local anesthesia.

Training cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• age above or equal to 18-year-old
• fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis
• signed informed consent

You may not qualify if:

• Non-cirrhotic portal hypertension
• Lactation or pregnancy
• Suspicious or confirmed hepatocellular carcinoma
• Asplenia or splenectomy
• Incomplete clinical information

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• LanZhou University: collaborator
• Shulan (Hangzhou) Hospital: collaborator
• The Third People's Hospital of Taiyuan: collaborator

Study Sites (3)

Shulan (Hangzhou) Hospital

Hangzhou, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

The Third People's Hospital of Taiyuan

Taiyuan, China

Location

Related Publications (8)

• 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.

  PMID: 30215362 BACKGROUND

• 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: 26047908 BACKGROUND

• 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.

  PMID: 14767976 BACKGROUND

• 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.

  PMID: 18397389 BACKGROUND

• 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.

  PMID: 22643348 BACKGROUND

• 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.

  PMID: 17464971 BACKGROUND

• 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.

  PMID: 29731186 BACKGROUND

• 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.

  PMID: 31444849 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lanjuan Li, MD

  Shulan (Hangzhou) Hospital

  STUDY CHAIR

• Xiaolong Qi, MD

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Huadong Yan, MD

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolong Qi, MD

CONTACT

+8618588602600; qixiaolong@vip.163.com

Ruiling He, MD

CONTACT

+8618153674392; 1037039754@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 22, 2021
• Study Start: September 28, 2023
• Primary Completion: September 27, 2025
• Study Completion: September 27, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (3)