An observational study in Liver Cirrhosis and Gastroesophageal Varices, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Observational
This retrospective cross-sectional diagnostic study compared the diagnostic performance of ultrasound-measured spleen thickness (ST) and spleen diameter (SD) against esophagogastroduodenoscopy (EGD) for gastroesophageal varices (GOV) and high-risk varices (HRV) detection in patients with compensated cirrhosis.
The authors, including senior physicians in infectious diseases and ultrasound, reviewed the medical records and the following data were recorded on a case report form: participants' demographic, etiologic, and laboratory data; SD, ST, portal vein diameter (PVD) and spleen vein diameter (SVD) values; liver stiffness measurement (LSM), spleen stiffness measurement (SSM) by transient elastography (TE); and EGD results.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 364 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 59 studies on the registry; 21 are open to participants now.
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Adult patients (age ≥18 years) with compensated cirrhosis were enrolled at The Fifth Affiliated Hospital, Sun Yat-sen University from January 2019 to June 2026.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is an retrospective cross-sectional diagnostic study. All participants included will be in one study group. Reference standard: EGD. The study used EGD (Olympus 260 or 290) as the reference standard for GOV and HRV detection. Index test: spleen size. An experienced sonographer blindly re-reviewed the patients' previous abdominal ultrasonographic images to assess for ultrasonographic evidence of cirrhosis and to measure SD, ST, portal vein diameter (PVD) and spleen vein diameter (SVD) values. SD was defined as the maximum distance between the dome of the spleen and the spleen tip, while ST was defined as the maximum distance between the medial and lateral borders of the spleen.
Diagnostic Test: spleen diameter · Diagnostic Test: spleen thickness · Diagnostic Test: esophagogastroduodenoscopy (EGD)
Spleen diameter was measured during abdominal ultrasound examination, and was defined as the maximum distance between the splenic dome and the splenic tip.
Spleen thickness was measured during abdominal ultrasound examination, and was defined as the maximum distance between the medial and lateral borders of the spleen
The study used EGD (Olympus 260 or 290) as the reference standard for GOV and HRV detection.
Gastroesophageal Varices
Presence of gastroesophageal varices (GOV), recorded as present or absent, determined by esophagogastroduodenoscopy (EGD)
Time frame: From January 2019 to June 2026 (retrospective medical record review)
high-risk varices
High-risk varices (HRV) was diagnosed when either of the following criteria was met: (1) variceal diameter ≥ 0.5 cm, or (2) the presence of more than one risk factor for variceal bleeding, such as red signs.
Time frame: From January 2019 to June 2026 (retrospective medical record review)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fifth Affiliated Hospital, Sun Yat-Sen University