CClinicalTrials.gg
Not yet recruitingNCT05052892Updated Apr 25, 2023

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

An observational study in Portal Hypertension, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Portal Hypertension

Keywords

  • cirrhosis
  • spleen stiffness
  • portal hypertension
  • hepatic venous pressure gradient
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testHepatic venous pressure gradient

    All patients underwent measurement of HVPG under local anesthesia.

05

What researchers measure

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.

    Time frame: 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

    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.

    Time frame: 3 years

06

Study locations

3 sites
  • Shulan (Hangzhou) Hospital
    Hangzhou, China
    • Huadong Yan · Contact
    • Huadong Yan, MD · Principal investigator
  • The First Hospital of Lanzhou University
    Lanzhou, China
    • Liting Zhang · Contact
    • Liting Zhang, MD · Principal investigator
  • The Third People's Hospital of Taiyuan
    Taiyuan, China
    • Ying Guo · Contact
    • Ying Guo, MD · Principal investigator
07

References and documents

Publications

  • 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. PubMed 30215362 ↗
  • 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. PubMed 26047908 ↗
  • 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. PubMed 14767976 ↗
  • 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. PubMed 18397389 ↗
  • 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. PubMed 22643348 ↗
  • 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. PubMed 17464971 ↗
  • 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. PubMed 29731186 ↗
  • 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. PubMed 31444849 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05052892
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Collaborators
LanZhou University, Shulan (Hangzhou) Hospital, The Third People's Hospital of Taiyuan
Responsible party
Xiaolong Qi (Professor, Hepatopancreatobiliary Surgery Institute of Gansu Province) — Principal investigator
First posted
Sep 22, 2021
Start date
Sep 28, 2023 (estimated)
Primary completion
Sep 27, 2025 (estimated)
Completion
Sep 27, 2025 (estimated)
Last update
Apr 25, 2023

Study contacts

Xiaolong Qi, MD
Contact
qixiaolong@vip.163.com
+8618588602600
Ruiling He, MD
Contact
1037039754@qq.com
+8618153674392
Lanjuan Li, MD
study chair · Shulan (Hangzhou) Hospital
Xiaolong Qi, MD
principal investigator · LanZhou University
Huadong Yan, MD
principal investigator · Shulan (Hangzhou) Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion