Liver CirrhosisNCT07920744
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
An observational study of Liver Cirrhosis and Gastroesophageal Varices, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Gastroesophageal Varices
- What is being tested?
- spleen diameter, spleen thickness and esophagogastroduodenoscopy (EGD)
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 11 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years;
- compensated cirrhosis;
Who cannot join
- history of hepatic decompensation, such as ascites, EVB, and hepatic encephalopathy;
- non-cirrhotic portal hypertension;
- digestive system malignancies such as hepatocellular carcinoma, pancreatic carcinoma, or other malignant tumors infiltrating the digestive system;
- acute liver disease, or serum total bilirubin ≥ 100 μmol/L;
- history of splenectomy;
- acute or chronic portal vein thrombosis;
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- pregnancy;
- concomitant HIV infection;
- prior TIPS, endoscopic variceal ligation (EVL), or endoscopic injection sclerotherapy (EIS);
- receipt of non-selective beta-blockers (NSBBs) or diuretics within 3 months before EGD or abdominal ultrasonography;
- persistent drug abuse other than alcohol;
- an interval of more than 6 months between abdominal ultrasonography and EGD, or the absence of results from either examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, 519000
Xi Liu, MD,PhD, +86-15992670630, liuxi26@mail.sysu.edu.cn
Chenyue Jin, +86-18025084237, jinchy5@mail2.sysu.edu.cn
About this study
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.
- Conditions
- Liver Cirrhosis, Gastroesophageal Varices
- Being tested
- spleen diameter, spleen thickness, esophagogastroduodenoscopy (EGD)
- Keywords
- spleen size, esophageal and gastric varices, compensated cirrhosis, non-invasive diagnostic model, machine learning
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spleen diameterDiagnostic test
Spleen diameter was measured during abdominal ultrasound examination, and was defined as the maximum distance between the splenic dome and the splenic tip.
spleen thicknessDiagnostic test
Spleen thickness was measured during abdominal ultrasound examination, and was defined as the maximum distance between the medial and lateral borders of the spleen
esophagogastroduodenoscopy (EGD)Diagnostic test
The study used EGD (Olympus 260 or 290) as the reference standard for GOV and HRV detection.
| Study group | Role | What they receive |
|---|---|---|
| study group | 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. Receives: Diagnostic Test: spleen diameter; Diagnostic Test: spleen thickness; Diagnostic Test: esophagogastroduodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophageal Varices
Presence of gastroesophageal varices (GOV), recorded as present or absent, determined by esophagogastroduodenoscopy (EGD)
Measured: 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.
Measured: From January 2019 to June 2026 (retrospective medical record review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start28 Oct 2026
- Primary completion28 Oct 2026
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Liu, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920744
- Sponsor's protocol ID
- 1501(2025-218)
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT07920744
- Acronym / sponsor ID
- 1501(2025-218)
- Conditions
- Liver Cirrhosis, Gastroesophageal Varices
- Keywords
- spleen size, esophageal and gastric varices, compensated cirrhosis, non-invasive diagnostic model, machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 28 Oct 2026 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: spleen diameter, Diagnostic Test: spleen thickness, Diagnostic Test: esophagogastroduodenoscopy (EGD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Age ≥18 years;
- compensated cirrhosis;
Key exclusion criteria (12 listed)
- history of hepatic decompensation, such as ascites, EVB, and hepatic encephalopathy;
- non-cirrhotic portal hypertension;
- digestive system malignancies such as hepatocellular carcinoma, pancreatic carcinoma, or other malignant tumors infiltrating the digestive system;
- acute liver disease, or serum total bilirubin ≥ 100 μmol/L;
- history of splenectomy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spleen diameterSpleen diameter was measured during abdominal ultrasound examination, and was defined as the maximum distance between the splenic dome and the splenic tip. | Diagnostic test | study group |
| spleen thicknessSpleen thickness was measured during abdominal ultrasound examination, and was defined as the maximum distance between the medial and lateral borders of the spleen | Diagnostic test | study group |
| esophagogastroduodenoscopy (EGD)The study used EGD (Olympus 260 or 290) as the reference standard for GOV and HRV detection. | Diagnostic test | study group |
Primary outcome
Gastroesophageal Varices
Time frame: From January 2019 to June 2026 (retrospective medical record review)
Presence of gastroesophageal varices (GOV), recorded as present or absent, determined by esophagogastroduodenoscopy (EGD)
high-risk varices
Time frame: From January 2019 to June 2026 (retrospective medical record review)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Gastroesophageal Varices, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Liu (15992670630, liuxi26@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Varices (time frame: From January 2019 to June 2026 (retrospective medical record review)). The study lists 2 primary outcomes in all. 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 6 Nov 2026.