- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825848
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Jianjun Luo, Doctor
- Phone Number: +86 13801924777
- Email: luo.jianjun@zs-hospital.sh.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Department of Interventional Radiology, Zhongshan Hospital, Fudan University
-
Contact:
- Jianjun Luo, MD
- Email: zhangzihan0217@126.com
-
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:
- The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;
- Clinically diagnosed post-hepatitis B cirrhosis;
- History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment;
- Liver function Child A or B;
- Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt;
- Platelet count ≥ 50 × 109 / L;
- Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds;
- Serum creatinine concentration ≤115umol/L;
- Patients and their families agree to join the clinical trial and sign an informed consent form.
Exclusion Criteria:
- Imaging confirms portal vein thrombosis;
- Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt);
- Combine any malignant tumor;
- History of previous hepatic encephalopathy;
- Consolidation of intractable ascites;
- Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency;
- 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.
Sponsor
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.
General Publications
- 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 reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
- 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 Association for the Study of Liver Diseases. J Hepatol. 2014 Sep;61(3):642-59. doi: 10.1016/j.jhep.2014.05.042. Epub 2014 Jul 8. No abstract available. Erratum In: J Hepatol. 2015 Oct;63(4):1055.
- 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 Diagnosis of Covert Hepatic Encephalopathy. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1828-1835.e1. doi: 10.1016/j.cgh.2014.05.011. Epub 2014 May 17.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2018-292R
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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