NCT01410591

Brief Summary

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

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

August 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

August 4, 2011

Last Update Submit

January 23, 2016

Conditions

Decompensated CirrhosisPortal HypertensionBleeding Varices

Keywords

transjugular intrahepatic portosystemic shuntTIPSliver cirrhosisvariceal bleeding8- or 10-mm covered stent

Outcome Measures

Primary Outcomes (1)

  • Incidence of shunt dysfunction.

    2 years

Secondary Outcomes (4)

  • Incidence of variceal rebleeding

    2 years

  • Incidence of hepatic encephalopathy

    2 years

  • Survival

    2 years

  • Incidence of hepatic myelopathy

    2 years

Study Arms (2)

10-mm covered stent group

ACTIVE COMPARATOR

Patients treated with 10-mm covered stent.

Device: 10-mm covered stent group

8-mm covered stent group

ACTIVE COMPARATOR

Patients treated with 8-mm covered stent.

Device: 8-mm covered stent group

Interventions

8-mm covered stent groupDEVICE

Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.

8-mm covered stent group
10-mm covered stent groupDEVICE

Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.

10-mm covered stent group

Eligibility Criteria

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

You may qualify if:

  • Cirrhotic patients with at least one episode of variceal bleeding
  • No active bleeding within 5 days before TIPS
  • Child-Pugh score ≤13
  • Signed written informed consent

You may not qualify if:

  • An age \<18 years or \>75 years
  • With TIPS contraindications
  • Past or present history of hepatic encephalopathy
  • Pregnancy or breast-feeding
  • Hepatic carcinoma and/or other malignancy diseases
  • Sepsis
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • Portal vein thrombosis
  • History of organ transplantation
  • History of HIV (human immunodeficiency viruses) infection

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

Related Publications (2)

  • Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.

    PMID: 20537753BACKGROUND

  • 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: 28506905DERIVED

MeSH Terms

Conditions

Hypertension, PortalLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Digestive Interventional Radiology

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 5, 2011

Study Start

July 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CN(1)