Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Anticoagulants and Bleeding Disorders Clinical Trial

Official title:

Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545475
• Other study ID #: 20220117-Qilu
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 18, 2024

Study information

• Verified date: January 2022
• Source: Qilu Hospital of Shandong University
• Contact: Yanjing Gao, PhD.
• Phone: 18560086087
• Email: gaoyanjing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Esophageal and Gastric Varices
• Gastric Varices Bleeding
• Hemorrhage
• Hemostatic Disorders
• Tissue Adhesion
• Tissue Adhesions
• Varicose Veins

Intervention

Drug:
• Low molecular weight heparin
Anticoagulants were given. When using warfarin, international normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Shandong Provincial Hospital, Taian City Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of a bleeding episode from glue cast extrusion	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	6-month
Secondary	death	death from all causes of illness related to liver dysfunction	6-month