The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

August 8, 2019 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Interventional Radiology, Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Zhinping Yan, MD
        • Sub-Investigator:
          • Jianjun Luo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left Portal Vein Branch
Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt
Shunting left or right PV branch in the TIPS procedure
Experimental: Right Portal Vein Branch
Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt
Shunting left or right PV branch in the TIPS procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of HE
Time Frame: 2 years
compare difference incidence of HE between shunting left and right portal vein branch
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jianjun Luo, doctor, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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