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Recruiting NCT06013670

NCT06013670 Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding

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Clinical Trial Summary
NCT ID NCT06013670
Status Recruiting
Phase
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Condition Portal Hypertension
Study Type INTERVENTIONAL
Enrollment 86 participants
Start Date 2023-01-01
Primary Completion 2026-05-01

Trial Parameters

Condition Portal Hypertension
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Type INTERVENTIONAL
Phase N/A
Enrollment 86
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-01-01
Completion 2026-05-01
Interventions
Endoscopy+NSBBsTransjugular intrahepatic portosystemic shunt

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Brief 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 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 t

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