RecruitingNot ApplicableNCT06013670

Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding

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


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

86 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Comparison of endoscopic therapy combined with non-selective therapy β Receptor blockers (NSBBs) and TIPS in the treatment of liver cirrhosis The impact of reducing bleeding on the survival of critically ill patients. To compare the effect of endoscopic therapy combined with NSBBs drugs and TIPS on rebleeding and incidence of Hepatic encephalopathy in patients with moderate risk of liver cirrhosis hemorrhage.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two strategies for preventing bleeding from enlarged veins in the esophagus or stomach (varices) in people with liver cirrhosis and moderately elevated pressure in the liver's blood supply. One approach uses standard medications (beta blockers); the other adds a procedure called TIPS (a small tube inserted in the liver to reduce pressure). **You may be eligible if...** - You are between 18 and 80 years old - You have confirmed liver cirrhosis caused by viral hepatitis or alcohol use - You have moderate-to-severe esophageal or stomach varices with at least one prior bleeding episode - Your liver pressure (HVPG) is between 16 and 20 mmHg - Your liver function is at Child-Turcotte-Pugh grade B or C (but less than 14 points) - You have a life expectancy of more than 1 year **You may NOT be eligible if...** - Your cirrhosis is from non-viral, non-alcohol causes - You cannot take beta blockers (e.g., you have asthma, serious heart block, or severe heart failure) - Your bilirubin is very high (>85.5 µmol/L) - You have liver cancer or severe organ dysfunction - You have uncontrolled fluid buildup or kidney-liver syndrome - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopy+NSBBs

Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure\>90mmHg and heart rate\>55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.

PROCEDURETransjugular intrahepatic portosystemic shunt

TIPS group: All TIPS procedures are completed by a professional liver disease intervention treatment team.


Locations(1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

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NCT06013670


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