NCT02156232

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 hepatic encephalopathy (HE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

6.7 years

First QC Date

June 3, 2014

Last Update Submit

October 22, 2022

Conditions

Liver Cirrhosis

Keywords

hepatic encephalopathy (HE)vericeal bleedingspontaneous portosystemic shunts (SPSS)transjugular intrahepatic portosystemic shunt (TIPS)embolization

Outcome Measures

Primary Outcomes (1)

  • Number and severiy of participants with overt hepatic encephalopathy

    2 years

Secondary Outcomes (5)

  • Number of participants with variceal rebleeding

    2 years

  • Number of participants with shunt dysfunction

    2 years

  • Change of liver function

    2 years

  • All-cause mortality

    2 years

  • Adverse events

    2 years

Study Arms (2)

TIPS, SPSS Emboliaztion

ACTIVE COMPARATOR

The covered stents wil be used for TIPS The SPSS will be embolized during the procedure of TIPS

Procedure: TIPSProcedure: SPSS embolization

TIPS alone

ACTIVE COMPARATOR

The covered stents will be used for TIPS No embolization of SPSS will be performed during TIPS

Procedure: TIPS

Interventions

TIPSPROCEDURE

TIPS is performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

TIPS aloneTIPS, SPSS Emboliaztion
SPSS embolizationPROCEDURE

Embolization of SPSS will be 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 or Amplatzer Vascular Plug, which resulted in the SPSS disappearing at postembolization angiography.

TIPS, SPSS Emboliaztion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Dignosis of liver cirrhosis (clinical or by liver biopsy)
  • Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed
  • Confirmed spontaneous portosystemic shunts in abdominal imagings
  • Sum of targeted spontaneous portosystemic shunts diameters greater than half the diameter of portal vein

You may not qualify if:

  • Hepatic carcinoma and/or other malignancy diseases
  • Portal vein thrombosis (≥50% of the lumen)
  • Budd-Chiari syndrome
  • Child-Pugh score\>13 points
  • Sepsis
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • With TIPS contraindications
  • Spontaneous recurrent hepatic encephalopathy
  • Previous TIPS or collateral embolization
  • Pregnancy or breast-feeding
  • History of liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Liver CirrhosisHepatic Encephalopathy

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Guohong Han, PhD,MD

    Xijing Hospital of Digestive Diseases, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

June 15, 2014

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

CN(1)