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The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT03825848
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Hepatic Encephalopathy Procedure: trans jugular intrahepatic portal systemic shunt Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Left Portal Vein Branch
Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt
 Procedure: 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
 Procedure: trans jugular intrahepatic portal systemic shunt
Shunting left or right PV branch in the TIPS procedure


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of HE [ Time Frame: 2 years ]
    compare difference incidence of HE between shunting left and right portal vein branch


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825848


Contacts
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Contact: Jianjun Luo, Doctor +86 13801924777 luo.jianjun@zs-hospital.sh.cn

Locations
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China, Shanghai
Department of Interventional Radiology, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianjun Luo, MD       zhangzihan0217@126.com   
Principal Investigator: Zhinping Yan, MD         
Sub-Investigator: Jianjun Luo, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Jianjun Luo, doctor Fudan University
More Information
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Publications of Results:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03825848    
Other Study ID Numbers: B2018-292R
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Portal
Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
 Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases