Clinical trial NCT06319131: Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT
Official title: Comparative Effectiveness of Nadroparin Versus Transjugular Intrahepatic Portosystemic Shunt in Cirrhotic Patients With Refractory Asymptomatic Portal Vein Thrombosis：a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Vein Thrombosis
Keywords: portal vein thrombosis
liver cirrhosis
nadroparin
transjugular intrahepatic portosystemic shunt
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: ShuGuang Hospital
name: Tongji Hospital
name: Renmin Hospital of Wuhan University
First posted: 2024-03-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: complete recanalization rate of PVT
timeFrame: 6 months
Secondary outcomes:
measure: partial recanalization rate of PVT
timeFrame: 6 months
measure: Bleeding rate
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: