Clinical study on the correlation between gastroesophageal varices and spleen stiffness measured with Fibroscan630

JRCT ID: jRCTs032200119

Registered date:15/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic liver disease
• Date of first enrollment: 08/10/2020
• Target sample size: 123
• Study type: Interventional
• Intervention(s): Visit once with a fast for more than 12 hours to perform Fibroscan 630 for out-of-insurance care

Outcome(s)

• Primary Outcome: Correlation between the presence of gastroesophageal varices and spleen stiffness measured with Fibroscan630

Secondary Outcome

(1) Performance evaluation of SSM by comparing the results of @100Hz and @50Hz
(2) Comparison of measurement success rates (10 effective measurements/total number of measurements) at @100Hz and @50Hz for SSM
(3) Comparison of egastroesophageal varices and liver stiffness measured with FibroScan 630
(4) Comparison of LSM @50Hz, SSM @100Hz, and SSM @50Hz with platelet counts, liver fibrosis markers (M2BPGi, type IV collagen 7S, autotaxin, and hyaluronic acid), and various scoring (AAR, APRI, Fib-4 index, LSPS, PSR)
(5) Comparison of hepatic venous pressure gradient with LSM @50Hz, SSM @100Hz, and SSM @50Hz

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) Men and women aged 20 to 90 at the time of registration
(2) Patients diagnosed with chronic liver disease (hepatitis B virus, hepatitis C virus, nonalcoholic fatty liver disease/nonalcoholic steatohepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, vascular diseases of the liver, hepatocellular carcinoma) 12 weeks or more before registration date.
(3) Patients who performed or is planning th perform upper gastrointestinal endoscopy 12 weeks or more before registration date.
(4) In the case of paients with hepatocellular carcinoma, patients undergoing or scheduled to perform contrast CT and MRI within 12 weeks before the enrollment date
(5) Any previous treatment for esophagogastric varices
(6) Patients who have written informed consent to participate in this study

Exclude criteria

(1) Patients with ascites around the spleen
(2) Patients who are pregnant or may be pregnant
(3) Patients using a pacemaker
(4) Patients with malignant tumors except hepatocellular carcinoma (However, patients who have undergone radical surgery or patients who have completed administration of chemotherapy can be registered, but patients under progress evaluation are excluded)
(5) Patients who have already undergone an endoscopy within 24 weeks of the date of consent and within 12 weeks of the date of consent
(6) Patietns with gastroesophageal varices with red or white plug findings on upper gastrointestinal endoscopy
(7) AST >=250 IU/L
(8) Platelet count <10,000/uL
(9) T-bil >=10.0 mg/dL
(10) Patients after splenectomy
(11) Other patients who are judged to be unsuitable as a target by the doctor's judgment

Related Information

• Primary Sponsor: Yasushi Honda