TIPS or Anticoagulation in Portal Vein Thrombosis (PROGRESS)

Insel Gruppe AG, University Hospital Bern

Status and phase: Withdrawn; Phase 3

Conditions: Thrombosis Portal Vein

Treatments: Device: TIPS; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03422419

IICT2017_PROGRESS

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

TIPS+Anticoagulation

Experimental group

Treatment:

Device: TIPS

Drug: Heparin

Anticoagulation

Active Comparator group

Treatment:

Drug: Heparin