Clinical trial NCT06961474: Effectiveness of Treatments for Cirrhosis With Varicose Veins
Official title: Effectiveness of Treatments for Cirrhosis With Varicose Veins：A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Varices Bleeding
Portal Hypertension
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.

Brief summary: Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. Patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. Esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. Current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical interventions. However, mortality remains high, and each treatment modality has its own limitations and controversies.

This study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis B, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. The study includes patients admitted for portal hypertension-related esophagogastric varices from February 2022 to December 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. Baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and Child-Pugh classification, will be collected. Follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. The primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications.

The sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. Statistical analysis will be performed using SPSS 24.0 and R software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or Fisher's exact test. The study has been approved by the ethics committee, and informed consent will be obtained from all participants.


Eligibility criteria: Inclusion Criteria:

① Age greater than 18 years, with no gender restriction.

② Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.

Exclusion Criteria:

* Age \< 18 years ② Absence of esophageal or gastric varices ③ Incomplete medical history records

Primary outcomes:
measure: Rebleeding within one year
timeFrame: 1 year
Secondary outcomes:
measure: Mortality within 1 year and the occurrence of portal hypertension-related complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: