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The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Primary Purpose

Portal Hypertension, Hepatic Encephalopathy

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

trans jugular intrahepatic portal systemic shunt

About this trial

This is an interventional treatment trial for Portal Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Left Portal Vein Branch

Right Portal Vein Branch

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of HE

compare difference incidence of HE between shunting left and right portal vein branch

Secondary Outcome Measures

Full Information

NCT ID

NCT03825848

First Posted

January 30, 2019

Last Updated

August 8, 2019

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03825848

Brief Title

The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Recruiting

Study Start Date

June 20, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Portal Hypertension, Hepatic Encephalopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Left Portal Vein Branch

Arm Type

Experimental

Arm Description

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

Arm Title

Right Portal Vein Branch

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

trans jugular intrahepatic portal systemic shunt

Intervention Description

Shunting left or right PV branch in the TIPS procedure

Primary Outcome Measure Information:

Title

The incidence of HE

Description

compare difference incidence of HE between shunting left and right portal vein branch

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianjun Luo, Doctor

Phone

+86 13801924777

luo.jianjun@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, doctor

Organizational Affiliation

Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

zhangzihan0217@126.com

First Name & Middle Initial & Last Name & Degree

Zhinping Yan, MD

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28506905

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 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.

Results Reference

result

PubMed Identifier

25015420

Citation

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.

Results Reference

result

PubMed Identifier

24846278

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 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.

Results Reference

result

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The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

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