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Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Refractory Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02156232
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

Brief Summary:
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective in the prevention of refractory hepatic encephalopathy (HE).

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: TIPS Procedure: embolization Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Refractory Hepatic Encephalopathy: a Prospective、Open-labeled、Randomized、Controlled Trial
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: TIPS,Emboliaztion
The covered stents were used for TIPS The SPSS will be embolized during the procedure of TIPS
Procedure: TIPS
TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. TIPS revision was planned if any evidence of shunt dysfunction was seen.

Procedure: embolization
Embolization of SPSS was conducted via the same jugular vein before TIPS implantation. The major procedures included (a)angiography of SPSS after successful intrahepatic puncture of a branch of the portal vein and (b)embolization of SPSS with coils of varying diameters, which resulted in the SPSS disappearing at postembolization angiography.

Active Comparator: TIPS alone
The covered stents were used for TIPS No embolization of SPSS will be performed during TIPS
Procedure: TIPS
TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. TIPS revision was planned if any evidence of shunt dysfunction was seen.




Primary Outcome Measures :
  1. number and severiy of participants with HE, espcially the refractory HE [ Time Frame: one year ]

Secondary Outcome Measures :
  1. number of participants with variceal rebleeding [ Time Frame: one year ]
  2. number of participants with shunt dysfunction [ Time Frame: one year ]
  3. Number of participants with Child-Pugh score changing by 2 or more points or MELD score by 4 or more [ Time Frame: one year ]
  4. all cause mortality [ Time Frame: one year ]


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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:

  • Signed written informed consent
  • History of cirrhosis (clinical or by liver biopsy)
  • Admission due to at least one episode of variceal bleeding
  • No active bleeding within 5 days before TIPS
  • Confirmed splenorenal shunt, gastrorenal shunt or paraesophageal vein
  • Sum of targeted SPSS diameters greater than half the diameter of portal vein
  • Child-Pugh score ≤13

Exclusion Criteria:

  • Hepatic carcinoma and/or other malignancy diseases
  • Portal vein thrombosis (≥50% of the lumen)
  • Budd-Chiari syndrome
  • Other spontaneous portosystemic shunts
  • Acute bleeding from oesophageal or gastric varices
  • Sepsis
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • With TIPS contraindications
  • Pregnancy or breast-feeding
  • History of organ transplantation
  • History of HIV (human immunodeficiency viruses) infection

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): NCT02156232


Contacts
Contact: Chen Hui, MD 86-29-84771528 qychenhui@163.com
Contact: Guohong Han, PhD,MD 86-29-84771528 hangh@fmmu.edu.cn‍

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Guohong Han, MD,Ph.D    86-29-84771528    hangh@fmmu.edu.cn   
Contact: Hui Chen, MD    86-29-84771528    qychenhui@163.com   
Principal Investigator: Guohong Han, MD, PhD         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han, PhD,MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Responsible Party: Guohong Han, M.D., Ph.D., Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02156232     History of Changes
Other Study ID Numbers: TIPS-SPSS
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Keywords provided by Guohong Han, Fourth Military Medical University:
hepatic encephalopathy (HE)
vericeal bleeding
spontaneous portosystemic shunts (SPSS)
transjugular intrahepatic portosystemic shunt (TIPS)
embolization

Additional relevant MeSH terms:
Brain Diseases
Brain Diseases, Metabolic
Liver Cirrhosis
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Metabolic Diseases