Skip to content

Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05545475
Enrollment
100
Registered
2022-09-19
Start date
2022-01-01
Completion date
2024-01-18
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulants and Bleeding Disorders, Gastric Varices Bleeding, Tissue Adhesion

Keywords

anticoagulants, tissue glue, gastric varices

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.

Interventions

DRUGLow 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.

Sponsors

Shandong Provincial Hospital
CollaboratorOTHER_GOV
Taian City Central Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of a bleeding episode from glue cast extrusion6-monthhematemesis, 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

MeasureTime frameDescription
death6-monthdeath from all causes of illness related to liver dysfunction

Countries

China

Contacts

Primary ContactYanjing Gao, PhD.
gaoyanjing@sdu.edu.cn18560086087
Backup ContactYunqing Zeng, PhD.
z18863666093@163.com18863666093

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026