AzTrials
AzTrials

CirrhosisNCT03513887

Noninvasive Tests to Predict the Presence of Esophageal Varices in Patients With Liver Cirrhosis

An observational study of Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Liver cirrhosis is caused by chronic liver diseases, varices exist in 30 - 60% of patients with liver cirrhosis. Variceal bleeding is one of the most important complications of cirrhosis, accelerating the progression of decompensation to a stage at which the patient is at an extremely high risk of death. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis
How many people
111 participants
Where
1 siteChina
Study dates
28 Feb 2018to 12 Jan 2019
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In this cross-sectional study, we will prospectively collect patients with liver cirrhosis who fulfill all inclusion criterias and will be treated in the Department of Gastroenterology of the Second Affiliated Hospital of Xi'an Jiaotong University from March 2018 to December 2018.

Who may be able to join

  • Aged 18 - 80 years old;
  • Diagnosis of liver cirrhosis (Cirrhosis is diagnosed using standard laboratory, radiological, and physical examination findings, or by liver histology in equivocal cases);
  • Paired noninvasive tests (blood tests, TE, abdominal CT, and/or ultrasound) and endoscopy within 3 months;

Who cannot join

  • A body mass index > 35;
  • Severe cardiopulmonary diseases, renal failure,acute illness; infectious diseases;
  • Pregnant or breast-feeding subjects;
  • Previous splenectomy or liver transplantation;(文献55)
  • Previous β-blocker therapy;
  • Endoscopic treatments (band ligation or sclerotherapy);
Show all 11Show fewer
  • Previous surgery for portal hypertension or transjugular intrahepatic portosystemic stent shunt placement;
  • Portal vein or splenic vein thrombosis;
  • Current or past history of hepatocellular carcinoma;
  • Presence of severe ascites that might significantly hamper the accurate assessment of LSM;
  • Unreliable LSM with an interquartile range (IQR) to median value ratio (IQR/M) of > 0.3, a success rate of < 60% , or validated measurements of < 10;

Trial locations and contacts

1 site in 1 country.

China1 site
  • The second affiliated hospital of xi'an jiaotong university

    Xi'an, Shaanxi, 710004

Other trials in China

About this study

Liver cirrhosis is caused by chronic liver diseases, varices exist in 30 - 60% of patients with liver cirrhosis. Variceal bleeding is one of the most important complications of cirrhosis, accelerating the progression of decompensation to a stage at which the patient is at an extremely high risk of death. Endoscopy is the gold standard for the diagnosis of varices, However, periodic endoscopic screening in all cirrhotic patients might unnecessarily induce an invasive and expensive procedure, ultimately increasing not only the medical workload of endoscopy units, but also the financial burden of patients. To avoid unnecessary endoscopy in low- risk patients, some simple, non-invasive and accurate tests have been developed to identify EVs. Such as Transient elastography (TE) , which is a noninvasive tool that measures liver stiffness (LS) correlating to liver fibrosis stage. Moreover, the LS-spleen size-to-platelet ratio score (LSPS), which is a combination of three simple examination methods (LS, spleen size and platelet count) has been established to accurately predict EVs in patients with cirrhosis. Therefore, investigators design this cross-sectional study to assess these non-invasive tests in predicting the presence of EVs in patients with cirrhosis.

Read the detailed description

Liver cirrhosis is a result of excessive extracellular matrix deposition in the liver in response to chronic inflammatory injury triggered by chronic liver diseases. And Cirrhosis is classified in 2 distinct clinical stages, compensated (Currently, both terms : "compensated advanced chronic liver disease(cACLD)" and "compensated cirrhosis" are acceptable) and decompensated, defined by the presence or absence of overt clinical complications of cirrhosis (ascites, variceal hemorrhage, hepatic encephalopathy). Portal hypertension is a frequent complication of liver cirrhosis, a contributing fator for ascites and hepatic encephalopathy, and a direct cause of variceal hemorrhage. An increase in portal pressure leads to the development of portosystemic collateral circulation, of which varices are the most important clinical feature. In accordance with the Baveno II consensus conference, esophageal varices (EVs) were classified as absent, small (diameter < 5 mm) or large (diameter ≥ 5 mm). The presence of red wale marks on the variceal wall in EVs was also recorded. EVs at a high risk for bleeding were defined according to the Baveno V criteria as large EVs or small EVs with red signs or EVs in patients with Child-Pugh class C disease. varices exist in 30 - 60% of patients with liver cirrhosis, depending on the severity of Portal hypertension. The yearly rate of development of new cases is 5 - 10% , whereas the growth rate from small to large varices ranges between 5 and 30 %.

Variceal bleeding is the most important and the most lethal complication of cirrhosis, accelerating the progression of decompensation to a stage at which the patient is at an extremely high risk of death. Therefore, the diagnosis, prevention, and management of EVs are important for patients with cirrhosis. And screening for EVs in all patients with cirrhosis is also strongly recommended across guidelines and consensus statements. Endoscopy is the gold standard for the diagnosis of varices, and is recommended as the screening method to identify those who should undergo prophylactic treatment when the diagnosis of cirrhosis is made. Nonselective β-blockers significantly reduce the bleeding rate in more than half of patients with high-risk EVs (HEVs). However, as the prevalence of HEVs at any given point in time is 15 - 25%, the majority of subjects undergoing screening endoscopy either do not have varices, or have varices that do not require prophylactic therapy. Therefore, periodic endoscopic screening in all cirrhotic patients, especially low-risk groups, might unnecessarily induce an invasive and expensive procedure, ultimately increasing not only the medical workload of endoscopy units, but also the financial burden to patients, as the number of patients with chronic liver disease increases and their survival improves. Furthermore, compliance may be limited, because even asymptomatic patients may be required to repeatedly undergo an unpleasant endoscopic procedure, which usually requires conscious sedation decreasing work productivity, It also carries rare but serious complications. Patients might be reluctant to receive endoscopy and become discouraged in starting preventive measures. All of these reasons lead to decline in patient compliance with treatment and follow-ups. Meanwhile, the endoscopy-related complications reported by a related article is close to 0.1% of incidence.

To avoid unnecessary endoscopy in low-risk patients, some simple, non-invasive and accurate tests have been developed to identify EVs. Transient elastography (TE) is a noninvasive tool that measures liver stiffness (LS) correlating to liver fibrosis stage. While LS also shows potential in the prediction of EVs, its role is still under debate. Moreover, the LS-spleen size-to-platelet ratio score (LSPS), which is a combination of three simple examination methods (LS, spleen size and platelet count) has been established to accurately predict EVs in patients with cirrhosis. And recent Baveno VI recommended the combination of transient elastography and platelet count for ruling out HEVs in patients with chronic liver disease.

Although there is a correlation between these non-invasive tools and the presence of EVS or HEVs, the optimal cut-offs and their validities vary in the different studies with different etiologies. In addition, the qualities of EVs assessment have not been provided in these studies. Therefore, investigators design this cross-sectional study to assess these non-invasive tests in predicting the presence of EVs in patients with cirrhosis. This could prevent unnecessary endoscopy with related complications and costs. And the results of noninvasive tests will be compared with endoscopy (ie, the gold standard for diagnosing EVs).

Conditions
Cirrhosis
Keywords
cirrhosis,varices,variceal bleeding, noninvasive tests,TE
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03513887
Study groupRoleWhat they receive
Group/Cohortswe will prospectively collect patients with liver cirrhosis who fulfill all inclusion criterias and will be treated in the Department of Gastroenterology of the Second Affiliated Hospital of Xi'an Jiaotong University.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EVs and HEVs detected by endoscopy

    All patients will undergo or have been undergone endoscopy, endoscopy is performed by a small number of experienced endoscopy operators. The severity of varices and the presence of red signs will be recorded.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start28 Feb 2018
  3. Primary completion12 Jan 2019
  4. Study completion12 Jan 2019

Resources

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
Case crossover
Time perspective
Cross-sectional
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513887
Sponsor's protocol ID
2018016
Status last verified
Feb 2018
First submitted
29 Mar 2018
Last updated
29 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University 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: finished, as of the sponsor's last update on 29 May 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EVs and HEVs detected by endoscopy (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 May 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in