The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Fudan University

Status: Unknown

Conditions: Hepatic Encephalopathy; Portal Hypertension

Treatments: Procedure: trans jugular intrahepatic portal systemic shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT03825848

B2018-292R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;
2. Clinically diagnosed post-hepatitis B cirrhosis;
3. History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment;
4. Liver function Child A or B;
5. Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt;
6. Platelet count ≥ 50 × 109 / L;
7. Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds;
8. Serum creatinine concentration ≤115umol/L;
9. Patients and their families agree to join the clinical trial and sign an informed consent form.

Exclusion criteria

1. Imaging confirms portal vein thrombosis;
2. Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt);
3. Combine any malignant tumor;
4. History of previous hepatic encephalopathy;
5. Consolidation of intractable ascites;
6. Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency;
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Left Portal Vein Branch

Experimental group

Description:

Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt

Treatment:

Procedure: trans jugular intrahepatic portal systemic shunt

Right Portal Vein Branch

Experimental group

Description:

Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt

Treatment:

Procedure: trans jugular intrahepatic portal systemic shunt