Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

• Conditions: Anticoagulants and Bleeding Disorders; Tissue Adhesion; Gastric Varices Bleeding
• Interventions: Drug: Low molecular weight heparin

• Registration Number: NCT05545475
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Primary Completion: 2023-01-18
• Study Completion: 2024-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anticoagulation group	Low molecular weight heparin	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.

Primary Outcome Measures

Name	Time	Method
the incidence of a bleeding episode from glue cast extrusion	6-month	hematemesis, melena, or a ≥ 2 g drop in hemoglobin, with endoscopy-confirmed active spurting or oozing from the site of extrusion of glue casts, or an ulcer with an adherent clot or a visible vessel and no other sources of bleeding

Secondary Outcome Measures

Name	Time	Method
death	6-month	death from all causes of illness related to liver dysfunction

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China