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TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding (T8/10SVB)

Primary Purpose

Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
8-mm covered stent group
10-mm covered stent group
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis focused on measuring transjugular intrahepatic portosystemic shunt, TIPS, liver cirrhosis, variceal bleeding, 8- or 10-mm covered stent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10-mm covered stent group

8-mm covered stent group

Arm Description

Patients treated with 10-mm covered stent.

Patients treated with 8-mm covered stent.

Outcomes

Primary Outcome Measures

Incidence of shunt dysfunction.

Secondary Outcome Measures

Incidence of variceal rebleeding
Incidence of hepatic encephalopathy
Survival
Incidence of hepatic myelopathy

Full Information

First Posted
August 4, 2011
Last Updated
January 23, 2016
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01410591
Brief Title
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
Acronym
T8/10SVB
Official Title
The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices
Keywords
transjugular intrahepatic portosystemic shunt, TIPS, liver cirrhosis, variceal bleeding, 8- or 10-mm covered stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10-mm covered stent group
Arm Type
Active Comparator
Arm Description
Patients treated with 10-mm covered stent.
Arm Title
8-mm covered stent group
Arm Type
Active Comparator
Arm Description
Patients treated with 8-mm covered stent.
Intervention Type
Device
Intervention Name(s)
8-mm covered stent group
Intervention Description
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
Intervention Type
Device
Intervention Name(s)
10-mm covered stent group
Intervention Description
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
Primary Outcome Measure Information:
Title
Incidence of shunt dysfunction.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of variceal rebleeding
Time Frame
2 years
Title
Incidence of hepatic encephalopathy
Time Frame
2 years
Title
Survival
Time Frame
2 years
Title
Incidence of hepatic myelopathy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han, PhD & MD
Organizational Affiliation
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20537753
Citation
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.
Results Reference
background
PubMed Identifier
28506905
Citation
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.
Results Reference
derived

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TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding

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