Comparing treatments for bleeding in liver cirrhosis patients

Endoscopic Therapy+ β Receptor Blockers and TIPS Preventing Rebleeding in Moderate to High-risk Patients With Liver Cirrhosis, Esophageal and Gastric Varices A Multicenter, Prospective Parallel Open Clinical Study

This study is testing whether a combination of endoscopic therapy and beta-blockers works better than a special procedure called TIPS for treating bleeding in patients with liver cirrhosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06013670 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of endoscopic therapy combined with non-selective beta-blockers (NSBBs) and transjugular intrahepatic portosystemic shunt (TIPS) in treating moderate to high-risk patients with esophageal and gastric variceal bleeding due to liver cirrhosis. It aims to evaluate the impact of these treatments on rebleeding rates and the incidence of hepatic encephalopathy. The study focuses on patients with confirmed liver cirrhosis and moderate to severe varices, assessing their outcomes over time. By analyzing these interventions, the study seeks to improve management strategies for a critical complication of liver disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with liver cirrhosis caused by viral hepatitis or alcohol, experiencing moderate to severe varices and a history of variceal bleeding.

Not a fit: Patients with cirrhosis from non-viral hepatitis or those who have contraindications for NSBBs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of rebleeding and improve survival rates for patients with liver cirrhosis.

How similar studies have performed: Previous studies have shown that TIPS is superior to standard treatments for preventing rebleeding, indicating a promising approach for this patient population.

Eligibility criteria

Inclusion Criteria:

* Confirmed as liver cirrhosis (based on clinical, laboratory examination, imaging, or liver biopsy), and the disease is caused by viral hepatitis cirrhosis or alcoholic cirrhosis.
* 16mmHg ≤ HVPG ≤ 20mmHg
* Gastroscopy confirms moderate to severe esophageal and gastric varices (EV and GOV1 types) with at least one history of EGVB
* Age 18-80 years old and liver function CTP grading B or C\<14 points
* Sign the informed consent form;
* Expected survival time greater than 1 year

Exclusion Criteria:

* Patients with cirrhosis associated with non viral hepatitis or Alcoholic hepatitis Taking NSBBs or other medications to treat portal hypertension within the past 6 weeks
* Contraindication for the use of NSBBs, such as bronchial asthma, Cardiogenic shock, heart block (Ⅱ - Ⅲ degree atrioventricular block), severe or acute heart failure and sinus bradycardia
* Simultaneously taking drugs that affect the metabolism and absorption of NSBBs in the body
* TIPS recanalization treatment due to shunt failure
* Serum total bilirubin\>85.5 µ mol/L
* Preoperative evaluation reveals the presence of liver cancer or extrahepatic tumors, severe organ dysfunction, and other factors that affect expected survival disease
* Intractable ascites or hepatorenal syndrome
* Concomitant portal vein cavernous degeneration or severe portal vein system thrombosis
* Women who plan to become pregnant or are already pregnant or breastfeeding

Where this trial is running

Nanjing, Jiangsu

• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Feng Zhang

Conditions Portal Hypertension