The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

NCT03825848 | Unknown

• 1 other identifier: B2018-292R
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• The incidence of HE

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

  2 years

Study Arms (2)

Left Portal Vein Branch

EXPERIMENTAL

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

Procedure: trans jugular intrahepatic portal systemic shunt

Right Portal Vein Branch

EXPERIMENTAL

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

Procedure: trans jugular intrahepatic portal systemic shunt

Interventions

trans jugular intrahepatic portal systemic shunt PROCEDURE

Shunting left or right PV branch in the TIPS procedure

Left Portal Vein Branch; Right Portal Vein Branch

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 28506905 RESULT

• 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.

  PMID: 25015420 RESULT

• 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.

  PMID: 24846278 RESULT

• Ma J, Luo J, Zhang W, Zhou Y, Zhang Z, Yang M, Zhuang Z, Ma L, Yu J, Zhou X, Yan Z. The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for multicenter randomized blinded controlled trial. Trials. 2023 May 6;24(1):312. doi: 10.1186/s13063-023-07326-9.

  PMID: 37149647 DERIVED

MeSH Terms

Conditions

Hypertension, Portal; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jianjun Luo, doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Jianjun Luo, Doctor

CONTACT

+86 13801924777; luo.jianjun@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: January 31, 2019
• Study Start: June 20, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

CN (1)