The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    130
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 15 February 2022
platelet count
endoscopy
hepatitis
encephalopathy
cirrhosis
prothrombin
varices
esophageal varices
varicose veins
portosystemic shunt

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 incidence of rebleeding and survival in the left and right branches of the portal vein were compared.

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] found that implantation of 8 mm diameter is compared with the use of 10 mm diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS without affecting the shunt effect. To further evaluate the effect of "left/right branch of shunt portal" on hepatic encephalopathy after TIPS, we intend to conduct the following studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial study with Child classification, hope to guide TIPS in line with China's national conditions through the high-level evidence-based medical evidence obtained.

Details
Condition Portal Hypertension, Hepatic Encephalopathy
Treatment trans jugular intrahepatic portal systemic shunt
Clinical Study IdentifierNCT03825848
SponsorShanghai Zhongshan Hospital
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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