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

NCT03513887 | Completed

• 1 other identifier: 2018016
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis

Keywords

cirrhosis,varices,variceal bleeding, noninvasive tests,TE

Outcome Measures

Primary Outcomes (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.

  3 months

Study Arms (1)

Group/Cohorts

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinhai Wang

  The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 2, 2018
• Study Start: February 28, 2018
• Primary Completion: January 12, 2019
• Study Completion: January 12, 2019
• Last Updated: May 29, 2019

Record last verified: 2018-02

Locations

CN (1)