Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03031717
Other study ID # TIPS-NEOPORTA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2023

Study information

Verified date February 2020
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Aldo Torre
Phone 54870900
Email detoal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow.

Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.


Description:

Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date June 30, 2023
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Written informed consent

- Liver cirrosis or non-cirrhotic patients

- Portal vein thrombosis (degree of vessel obstruction > 50%)

Exclusion Criteria:

- Active variceal bleeding

- Prior history of TIPS placement or shunt surgery

- Concomitant renal insufficiency

- Severe cardiopulmonary diseases

- Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy

- Contraindications for TIPS

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transjugular intrahepatic portosystemic shunt


Locations

Country Name City State
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome of TIPS for PVT in patients with and without cirrhosis Clinical evolution after placement of TIPS 5 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT02250391 - Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis Phase 3
Recruiting NCT05625893 - Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion Phase 2
Completed NCT05012501 - Analysis of Neutrophil Extracellular Traps in Hypercoagulability and Portal Vein Thrombosis in Liver Cirrhosis Patients
Terminated NCT00769873 - Anticoagulation Post Laparoscopic Splenectomy Phase 2
Recruiting NCT05123326 - Global Coagulation Assessment in Portal Vein Thrombosis and Budd-Chiari Syndrome
Completed NCT01095185 - Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding Phase 3
Completed NCT02585713 - Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism Phase 3
Not yet recruiting NCT06117488 - Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children
Completed NCT01326949 - Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis N/A
Not yet recruiting NCT05339581 - IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation N/A
Recruiting NCT03902678 - Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma N/A
Not yet recruiting NCT06319131 - Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT N/A
Recruiting NCT03193502 - Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis Phase 3
Completed NCT03201367 - Efficacy and Safety of Rivaroxaban in Acute Non-neoplastic Portal Vein Thrombosis in HCV N/A
Completed NCT03477149 - EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications N/A
Recruiting NCT02398357 - The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis Phase 4
Completed NCT01556282 - TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis N/A
Withdrawn NCT01631877 - Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver N/A
Recruiting NCT04433481 - Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis N/A