NCT02119988

Brief Summary

The purpose of this study is to determine whether TIPS combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

6.4 years

First QC Date

April 17, 2014

Last Update Submit

October 22, 2022

Conditions

Liver Cirrhosis

Keywords

TIPSEmbolizationVariceal rebleeding

Outcome Measures

Primary Outcomes (1)

  • All-cause rebleeding

    2 years

Secondary Outcomes (6)

  • Variceal rebleeding

    2 years

  • Shunt dysfunction

    2 years

  • Hepatic encephalopathy

    2 years

  • Liver function changs

    2 years

  • Mortality

    2 years

  • +1 more secondary outcomes

Study Arms (2)

TIPS combined with variceal embolization

EXPERIMENTAL

The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS

Procedure: TIPSProcedure: Variceal Embolization

TIPS alone

ACTIVE COMPARATOR

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

Procedure: TIPS

Interventions

TIPSPROCEDURE

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

TIPS aloneTIPS combined with variceal embolization
Variceal EmbolizationPROCEDURE

Embolization of gastroesophageal collaterals will be conducted via the same jugular vein before TIPS implantation. The major procedures includ (a) angiography of gastroesophageal collaterals after successful intrahepatic puncture of a branch of the portal vein and (b) embolization of gastroesophageal collaterals with coils of varying diameters, which result in the gastroesophageal collaterals disappearing at postembolization angiography.

TIPS combined with variceal embolization

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 cirrhosis (clinical or by liver biopsy)
  • Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed
  • Age 18 to 75 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xijing Hospital of digestive disease, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Lv Y, Chen H, Luo B, Bai W, Li K, Wang Z, Xia D, Guo W, Wang Q, Li X, Yuan J, Cai H, Xia J, Yin Z, Fan D, Han G. Transjugular intrahepatic portosystemic shunt with or without gastro-oesophageal variceal embolisation for the prevention of variceal rebleeding: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Aug;7(8):736-746. doi: 10.1016/S2468-1253(22)00087-5. Epub 2022 May 17.

    PMID: 35588750DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

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

April 17, 2014

First Posted

April 22, 2014

Study Start

June 16, 2014

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

CN(2)