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Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

Primary Purpose

Decompensated Cirrhosis, Portal Vein Thrombosis, Bleeding Varices

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transjugular intrahepatic portosystemic shunt (TIPS)
ET+NSBB
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

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent
  • Liver cirrhosis
  • Portal vein thrombosis (degree of vessel obstruction > 50%)
  • History of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours)

Exclusion Criteria:

  • Uncontrolled active variceal bleeding
  • Fibrotic cord of the portal vein
  • Prior history of TIPS placement or shunt surgery or endoscopic ban ligation +NSBB
  • Concomitant renal insufficiency
  • Severe cardiopulmonary diseases
  • Uncontrolled systemic infection or sepsis
  • Malignancy or other serious medical illness which may reduce the life expectancy
  • Contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease
  • Contraindications for heparin or warfarin
  • Contraindications for TIPS

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

ET+NSBB

TIPS

Arm Description

Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL) Non-selective beta blocker(NSBB)-Propranolol. Anticoagulation(AT)- Heparin followed by warfarin.

Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.

Outcomes

Primary Outcome Measures

Number of participants with variceal rebleeding
Variceal rebleeding is the primary endpoint of this study. Cumulative variceal rebleeding rate is compared between the two groups.

Secondary Outcome Measures

Number of death
Death is a secondary endpoint of this study. Cumulative survival rate is compared between the two groups.
Number of participants achieving portal vein recanalization
Portal vein recanalization is a secondary endpoint of this study. Recanalization rate of thrombosed portal vein is compared between the two groups.
Changes of degree of PVT in patients without portal vein recanalization
We also observed changes of degree of portal vein thrombosis in patients without portal vein recanalization.
Number of complications
Complications include: TIPS-related complications: procedural complications, shunt dysfunction and hepatic encephalopathy. Complications related to endoscopic and drug treatment.

Full Information

First Posted
March 29, 2011
Last Updated
May 18, 2017
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01326949
Brief Title
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Official Title
Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis. However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.
Detailed Description
Usually, cirrhotic patients with PVT are submitted to variceal rebleeding prophylaxis with endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the anticoagulation is started after the varices eradication. TIPS is just regarded as the second-line therapy for the secondary prophylaxis of variceal bleeding in cirrhotic patients. However, this indication might be changed in the setting of PVT. Indeed, the risk to benefit ratio of TIPS in cirrhotic patients with PVT for the prevention of recurrent variceal bleeding has never been evaluated. The aim of this study is to compare the efficacy and safety of TIPS and endoscopic band ligation + propranolol in decompensated cirrhosis patients with PVT and a history of variceal bleeding in the past 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Portal Vein Thrombosis, Bleeding Varices

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ET+NSBB
Arm Type
Active Comparator
Arm Description
Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL) Non-selective beta blocker(NSBB)-Propranolol. Anticoagulation(AT)- Heparin followed by warfarin.
Arm Title
TIPS
Arm Type
Active Comparator
Arm Description
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.
Intervention Type
Procedure
Intervention Name(s)
Transjugular intrahepatic portosystemic shunt (TIPS)
Intervention Description
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. Postoperatively, intravenous heparin (8,000-12,000 u/d) for five days, warfarin for six months were given.
Intervention Type
Procedure
Intervention Name(s)
ET+NSBB
Intervention Description
ET-Esophageal varices was treated by endoscopic variceal ligation (EVL). EVL was repeated at intervals of 1-2 weeks until the varices were obliterated or reduced to grade-I size. NSBB-Propranolol started at a dose of 20mg twice a day. The dose is adjusted to the maximal tolerated doses to heart rate (HR) of 55 bpm or to decrease the HR 25% from baseline. AT-A continuously intravenous infusion of unfractionated heparin followed by oral warfarin is employed. Initially, heparin is administered intravenously for 5 days. Subsequently, oral warfarin is prescribed at the dosage of 2.5 mg/d for 6 months or until complete portal vein recanalization and adjusted to maintain the INR at a target of 2.5 (range 2.0-3.0).
Primary Outcome Measure Information:
Title
Number of participants with variceal rebleeding
Description
Variceal rebleeding is the primary endpoint of this study. Cumulative variceal rebleeding rate is compared between the two groups.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Number of death
Description
Death is a secondary endpoint of this study. Cumulative survival rate is compared between the two groups.
Time Frame
4 years
Title
Number of participants achieving portal vein recanalization
Description
Portal vein recanalization is a secondary endpoint of this study. Recanalization rate of thrombosed portal vein is compared between the two groups.
Time Frame
4 years
Title
Changes of degree of PVT in patients without portal vein recanalization
Description
We also observed changes of degree of portal vein thrombosis in patients without portal vein recanalization.
Time Frame
4 years
Title
Number of complications
Description
Complications include: TIPS-related complications: procedural complications, shunt dysfunction and hepatic encephalopathy. Complications related to endoscopic and drug treatment.
Time Frame
4 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: Written informed consent Liver cirrhosis Portal vein thrombosis (degree of vessel obstruction > 50%) History of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours) Exclusion Criteria: Uncontrolled active variceal bleeding Fibrotic cord of the portal vein Prior history of TIPS placement or shunt surgery or endoscopic ban ligation +NSBB Concomitant renal insufficiency Severe cardiopulmonary diseases Uncontrolled systemic infection or sepsis Malignancy or other serious medical illness which may reduce the life expectancy Contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease Contraindications for heparin or warfarin Contraindications for TIPS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han
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
20932597
Citation
Han G, Qi X, He C, Yin Z, Wang J, Xia J, Yang Z, Bai M, Meng X, Niu J, Wu K, Fan D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with symptomatic portal hypertension in liver cirrhosis. J Hepatol. 2011 Jan;54(1):78-88. doi: 10.1016/j.jhep.2010.06.029. Epub 2010 Aug 27.
Results Reference
background
PubMed Identifier
33089892
Citation
Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
Results Reference
derived
PubMed Identifier
28970291
Citation
Lv Y, Qi X, He C, Wang Z, Yin Z, Niu J, Guo W, Bai W, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Liu H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Xia J, Cai H, Yang Z, Wu K, Fan D, Han G; PVT-TIPS Study Group.. Covered TIPS versus endoscopic band ligation plus propranolol for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: a randomised controlled trial. Gut. 2018 Dec;67(12):2156-2168. doi: 10.1136/gutjnl-2017-314634. Epub 2017 Sep 28.
Results Reference
derived
PubMed Identifier
23847271
Citation
Qi X, He C, Yin Z, Wang Z, Zhang H, Yao L, Wang J, Xia J, Cai H, Yang Z, Bai M, Guo W, Niu J, Wu K, Fan D, Han G; PVT-TIPS Study Group. Transjugular intrahepatic portosystemic shunt for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: study protocol for a randomised controlled trial. BMJ Open. 2013 Jul 11;3(7):e003370. doi: 10.1136/bmjopen-2013-003370. Print 2013.
Results Reference
derived

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Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

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