TIPS or Anticoagulation in Portal Vein Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-07-31

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.

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Detailed Description

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Conditions

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Thrombosis Portal Vein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TIPS+Anticoagulation

Group Type EXPERIMENTAL

Heparin

Intervention Type DRUG

The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.

TIPS

Intervention Type DEVICE

transjugular intrahepatic portosystemic shunt deployment

Anticoagulation

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.

Interventions

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Heparin

The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.

Intervention Type DRUG

TIPS

transjugular intrahepatic portosystemic shunt deployment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Written informed consent

Exclusion Criteria

1. Malignant Portal Vein thrombosis (neoplastic invasion)
2. Intraabdominal malignancy
3. Chronic diseases limiting life expectancy in the short term (6 months)
4. Liver transplantation
5. Unwillingness to participate
6. Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2)
7. Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liver disease-

Eligible Sex

ALL

Accepts Healthy Volunteers

No