Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT

NCT ID: NCT06319131

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-30

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.

Conditions

Portal Vein Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TIPS group

The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt.

Group Type: EXPERIMENTAL

TIPS

Intervention Type: PROCEDURE

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.

Nadroparin group

The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy

Group Type: ACTIVE_COMPARATOR

Nadroparin

Intervention Type: DRUG

Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h

Interventions

TIPS

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.

Intervention Type: PROCEDURE

Nadroparin

Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

ShuGuang Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Central Contacts

Jie CHEN, MD

Role: CONTACT

chen.jie5@zs-hospital.sh.cn

8613764633539

Lili Liu, MD

Role: CONTACT

liu.lili@zs-hospital.sh.cn

862164041990-612632

Other Identifiers

Tipharosis

Identifier Type: -

Identifier Source: org_study_id