Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT

Not Applicable

Not yet recruiting

• Conditions: Portal Vein Thrombosis
• Interventions: Procedure: TIPS; Drug: Nadroparin

• Registration Number: NCT06319131
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial

Detailed Description

This research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (PVT) associated with liver cirrhosis. Building upon this, a randomized controlled study will be carried out for PVT patients with poor response to anticoagulant treatment. The study will compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) and prolonged anticoagulant therapy. The ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated PVT. This comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory PVT in liver cirrhosis.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Study Start: 2024-05-01
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Diagnosed with liver cirrhosis
• Diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter.
• Consent to participate in the clinical trial and the signing of an informed consent form.

Exclusion Criteria

• Presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation
• Patients with Child-Pugh C.
• Pregnant or lactating women.
• With a history of liver cancer or other malignancy.
• Severe heart, lung diseases, or significant renal dysfunction.
• Allergies to anticoagulant medications, uncontrolled hypertension, history of cerebral hemorrhage, discovery of gastrointestinal ulcers, ulcerative colitis, subacute bacterial endocarditis, or other contraindications to anticoagulant drugs.
• On concomitant therapy of immunosuppressive drugs.
• With coagulation disorders other than liver disease.
• With active variceal bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS group	TIPS	The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt.
Nadroparin group	Nadroparin	The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy

Primary Outcome Measures

Name	Time	Method
complete recanalization rate of PVT	6 months	Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. The primary outcome is the complete recanalization.

Secondary Outcome Measures

Name	Time	Method
partial recanalization rate of PVT	6 months	Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. Partial recanalization is defined as decrease of PVT more than 50%.
Mortality	6 months	Survival analysis
Bleeding rate	6 months	Bleeding events related to anticoagulant therapy. Bleeding events will be further classified into major and minor according to the established criteria outlined by the International Society of Thrombosis and Haemostasis