NCT01326949

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

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

March 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4.7 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

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

4.7 years

First QC Date

March 29, 2011

Last Update Submit

May 18, 2017

Conditions

Decompensated CirrhosisPortal Vein ThrombosisBleeding Varices

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 years

Secondary Outcomes (4)

  • Number of death

    4 years

  • Number of participants achieving portal vein recanalization

    4 years

  • Changes of degree of PVT in patients without portal vein recanalization

    4 years

  • Number of complications

    4 years

Study Arms (2)

ET+NSBB

ACTIVE COMPARATOR

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

Procedure: ET+NSBB

TIPS

ACTIVE COMPARATOR

Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Interventions

Transjugular intrahepatic portosystemic shunt (TIPS)PROCEDURE

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.

TIPS
ET+NSBBPROCEDURE

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).

ET+NSBB

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

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 (4)

  • 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.

    PMID: 20932597BACKGROUND

  • 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.

    PMID: 33089892DERIVED

  • 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.

    PMID: 28970291DERIVED

  • 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.

    PMID: 23847271DERIVED

MeSH Terms

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Guohong Han

    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

March 29, 2011

First Posted

March 31, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations

CN(1)