The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Portal Hypertension Clinical Trial

Official title:

The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825848
• Other study ID #: B2018-292R
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Jianjun Luo, Doctor
• Phone: +86 13801924777
• Email: luo.jianjun[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hypertension, Portal
• Portal Hypertension

Intervention

Procedure:
• trans jugular intrahepatic portal systemic shunt
Shunting left or right PV branch in the TIPS procedure

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

American Association for the Study of Liver Diseases; European Association for the Study of the Liver. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the European Association for the Study of the Liver and the American Associa — View Citation

Bajaj JS, Heuman DM, Sterling RK, Sanyal AJ, Siddiqui M, Matherly S, Luketic V, Stravitz RT, Fuchs M, Thacker LR, Gilles H, White MB, Unser A, Hovermale J, Gavis E, Noble NA, Wade JB. Validation of EncephalApp, Smartphone-Based Stroop Test, for the Diagno — View Citation

Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of HE	compare difference incidence of HE between shunting left and right portal vein branch	2 years