Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Shandong University

Status: Unknown

Conditions: Tissue Adhesion; Gastric Varices Bleeding; Anticoagulants and Bleeding Disorders

Treatments: Drug: Low molecular weight heparin

Study type: Observational

Funder types: Other

Identifiers

NCT05545475

20220117-Qilu

Details and patient eligibility

About

This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.

Full description

Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of cirrhosis
• Portal hypertension with gastric varices
• diagnosis of PVT by imaging examination
• undergo glue injection for gastric varices

Exclusion criteria

• hepatocellular carcinoma or other extrahepatic malignancy
• isolated portal cavernoma
• treatment with TIPS, thrombolysis, thrombectomy or liver transplantation
• previous long-term anticoagulation therapy for various reasons
• pregnant women
• previous endoscopic treatment of GVs

Trial design

100 participants in 2 patient groups

Anticoagulation group

Description:

1 mg/kg of nadroparin calcium or enoxaparin every 12 h, 5000 IU of low molecular weight heparin (LMWH) every 12 h, 20 mg of rivaroxaban once daily, or warfarin adjusted by an increase or decrease of 0.75 mg until the target international normalized ratio (INR) of 2-3 was reached.

Treatment:

Drug: Low molecular weight heparin

Control group

Description:

No anticoagulation group.