The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy

NCT02156232

Liver Cirrhosis

COMPLETED NA

Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation

NCT03372499

Hepatic Encephalopathy

UNKNOWN NA

Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

NCT06122753

Portal Hypertension Portal Vein Thrombosis Esophageal Varix Bleeding +1 more

NOT_YET_RECRUITING NA

Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

NCT01326949

Decompensated Cirrhosis Portal Vein Thrombosis Bleeding Varices

COMPLETED NA

Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis

NCT07253389

Liver Cirrhosis Gastroesophageal Varices Bleeding

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Portal Hypertension Hepatic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Left Portal Vein Branch

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

Group Type EXPERIMENTAL

trans jugular intrahepatic portal systemic shunt

Intervention Type PROCEDURE

Shunting left or right PV branch in the TIPS procedure

Right Portal Vein Branch

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

Group Type EXPERIMENTAL

trans jugular intrahepatic portal systemic shunt

Intervention Type PROCEDURE

Shunting left or right PV branch in the TIPS procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trans jugular intrahepatic portal systemic shunt

Shunting left or right PV branch in the TIPS procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No