Clinical trial NCT05545475: Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
Official title: Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulants and Bleeding Disorders
Tissue Adhesion
Gastric Varices Bleeding
Keywords: anticoagulants
tissue glue
gastric varices
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Taian City Central Hospital
First posted: 2022-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cirrhotic patients complicated with imaging-confirmed PVT and undergoing injection of tissue adhesive for GVs from three tertiary referral hospitals (Qilu Hospital of Shandong University, Shandong Provincial Hospital, and Taian City Central Hospital) were screened.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of a bleeding episode from glue cast extrusion
timeFrame: 6-month
Secondary outcomes:
measure: death
timeFrame: 6-month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanjing Gao, PhD.
role: PRINCIPAL_INVESTIGATOR
References: