Effectiveness of Treatments for Cirrhosis With Varicose Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism

NCT05055713

Liver Cirrhosis Esophageal and Gastric Varices Hypersplenism

UNKNOWN NA

Evaluation of Endoscopic Treatment Effect Based on HVPG

NCT06863519

Esophageal and Gastric Varices

ENROLLING_BY_INVITATION

Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

NCT02335580

Liver Cirrhosis Portal Vein Venous Thrombosis +2 more

COMPLETED

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension

NCT06970509

Esophageal Varices Portal Hypertension

RECRUITING

TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

NCT02485184

Portal Vein Thrombosis Liver Cirrhosis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Varices Bleeding Portal Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoscopic treatment group

Endoscopic treatment

Intervention Type PROCEDURE

The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.

Non-endoscopic treatment group

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic treatment

The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.