Status:
UNKNOWN
The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Portal Hypertension
Hepatic Encephalopathy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of stent patency, the inci...
Detailed Description
The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent studies \[14\] f...
Eligibility Criteria
Inclusion
- The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;
- Clinically diagnosed post-hepatitis B cirrhosis;
- History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment;
- Liver function Child A or B;
- Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt;
- Platelet count ≥ 50 × 109 / L;
- Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds;
- Serum creatinine concentration ≤115umol/L;
- Patients and their families agree to join the clinical trial and sign an informed consent form.
Exclusion
- Imaging confirms portal vein thrombosis;
- Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt);
- Combine any malignant tumor;
- History of previous hepatic encephalopathy;
- Consolidation of intractable ascites;
- Pulmonary artery pressure \> 40 mmHg, left ventricular ejection fraction \< 50%, congestive heart failure or severe valvular insufficiency;
- Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin \> 51umol / L failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant Or lactation; severe contrast allergy.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03825848
Start Date
June 20 2019
End Date
December 31 2023
Last Update
August 9 2019
Active Locations (1)
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1
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032