RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form; - Expected survival time greater than 1 year Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Endoscopy+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.

PROCEDURE

Transjugular 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