Status:
RECRUITING
Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Beijing Friendship Hospital
Conditions:
Portal Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
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 critic...
Detailed Description
Portal hypertension (PH) is one of the most common and serious adverse consequences of liver cirrhosis. Its complications, including esophageal and gastric variceal bleeding (EGVB), intractable ascite...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06013670
Start Date
January 1 2023
End Date
May 1 2026
Last Update
August 28 2023
Active Locations (1)
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1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China