TIPS or Anticoagulation in Portal Vein Thrombosis

Study Overview
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Brief Summary
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The PROGRESS is an investigator-initiated, multicentre, randomized, trial comparing anticoagulation, which is the currently most frequently used treatment, alone, versus transjugular intrahepatic portosystemic shunt (TIPS) combined with anticoagulation, in patients presenting with recent obstructive portal vein thrombosis (ROPVT). The rationale of this study is to significantly increase the proportion of patients that achieve a complete or partial recanalization of the portal vein. The intervention of this study consists in TIPS deployment and catheter based clot removal in addition to anticoagulation. The investigators retain that this intervention will increase the proportion of patients with an open portal vein from 38% with anticoagulation alone to 83% with anticoagulation and TIPS after 6 months. Both anticoagulant therapy and clot removal/TIPS are treatments that are currently available and accepted indications for the treatment of ROPVT. Anticoagulation will be performed with unfractioned heparin or low molecular weight heparin initially and with vitamin K antagonists in the long term. The investigators plan to collect blood for biobanking at the time of inclusion and after 6 months. Blood samples for a biobank will be collected.

Official Title
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An Investigator-initiated, Multicentre, Randomized, Trial Comparing Anticoagulation Alone Versus Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Anticoagulation in Patients With Recent Obstructive Portal Vein Thrombosis

Conditions
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Thrombosis Portal Vein

Intervention / Treatment
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* Drug: Heparin
* Device: TIPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent complete thrombosis of the extrahepatic portal vein either with or without the involvement of intrahepatic branches and with or without involvement of splenic vein and superior mesenteric vein Written informed consent Exclusion Criteria: Malignant Portal Vein thrombosis (neoplastic invasion) Intraabdominal malignancy Chronic diseases limiting life expectancy in the short term (6 months) Liver transplantation Unwillingness to participate Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2) Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liver disease-
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS+Anticoagulation<br> | Drug: Heparin<br>* The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.<br>Device: TIPS<br>* transjugular intrahepatic portosystemic shunt deployment<br>|
| Active Comparator: Anticoagulation<br> | Drug: Heparin<br>* The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with complete recanalization of the portal vein. |  | 6 month |