Effectiveness of Treatments for Cirrhosis With Varicose Veins

NCT06961474 | Active Not Recruiting

• 1 other identifier: B2022-109
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Varices Bleeding; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Rebleeding within one year

  1 year

Secondary Outcomes (1)

• Mortality within 1 year and the occurrence of portal hypertension-related complications

  1 year

Study Arms (2)

Endoscopic treatment group

Procedure: Endoscopic treatment

Non-endoscopic treatment group

Interventions

Endoscopic treatment PROCEDURE

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

Endoscopic treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Shiyao Chen, Ph.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: February 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

CN (1)