Portal Vein Thrombosis
Conditions
Keywords
portal vein thrombosis, liver cirrhosis, nadroparin, transjugular intrahepatic portosystemic shunt
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.
Interventions
PROCEDURETIPS
Using the transjugular approach, TIPS was created under local anesthesia. The first branch of the left or right portal vein (PV) was punctured by RUPS-100 set guided by digital subtraction angiography. After successful access into PV, direct portography was performed and all visible varices and/or concurrent spontaneous portosystemic shunts (SPSS) were embolized with coils and n-butyl cyanoacrylate. A polytetrafluoroethylene-covered stent (Viatorr Endoprosthesis, GORE and Associates, Flagstaff, Arizona, USA) with a diameter of 8 mm was implanted and fully dilated.
DRUGNadroparin
Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h
Sponsors
Shanghai 6th People's Hospital
ShuGuang Hospital
Tongji Hospital
Renmin Hospital of Wuhan University
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| 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 |
| Mortality | 6 months | Survival analysis |
Contacts
Primary ContactJie CHEN, MD
Backup ContactLili Liu, MD
Outcome results
None listed