Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding (NCT06013670) | Clinical Trial Compass
UnknownNot Applicable
Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding
China86 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 (â…¡ - â…¢ 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
What they're measuring
1
Rebleeding
Timeframe: 24 months
2
Hepatic encephalopathy
Timeframe: 24 months
Trial details
NCT IDNCT06013670
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School