The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Not Applicable

• Conditions: Hepatic Encephalopathy; Portal Hypertension
• Interventions: Procedure: trans jugular intrahepatic portal systemic shunt

• Registration Number: NCT03825848
• Lead Sponsor: Shanghai Zhongshan Hospital

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

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 \[14\] 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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-06-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Portal Vein Branch	trans jugular intrahepatic portal systemic shunt	Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt
Right Portal Vein Branch	trans jugular intrahepatic portal systemic shunt	Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt

Primary Outcome Measures

Name	Time	Method
The incidence of HE	2 years	compare difference incidence of HE between shunting left and right portal vein branch

Trial Locations

Locations (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China