Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal
Conditions
Keywords
Cirrhosis, Portal Vein Thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy, Hypersplenism, Azygoportal disconnection
Brief summary
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.
Detailed description
If portal vein thrombosis occurs more than one year after and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, the efficacy of apixaban in treating portal vein thrombosis will be examined every three months using Doppler ultrasound screening or contrast-enhanced CT scans. If it is effective, the patient will continue to take apixaban.
Interventions
DRUGApixaban 2.5 MG
If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology. 2. Portal hypertension bleeding . 3. Splenomegaly with secondary hypersplenism. 4. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery. 5. Underwent laparoscopic splenectomy at our center. 6. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3. 7. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3 8. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3. 9. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12. 10. Developed portal vein thrombosis after 12 months post-surgery. 11. Provided informed consent to participate in the study.
Exclusion criteria
1. Hepatocellular carcinoma or any other malignancy. 2. Hypercoagulable state other than the liver disease related. 3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs. 4. Child - Pugh C 5. Recent peptic ulcer disease 6. History of Hemorrhagic stroke 7. Pregnancy. 8. Uncontrolled Hypertension 9. Human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of complete recanalization of portal vein thrombosis | Follow-up of 6 months or greater | Proportion of complete recanalization of portal vein thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of partial recanalization of portal vein thrombosis | Follow-up of 6 months or greater | Proportion of partial recanalization of portal vein thrombosis |
Countries
China
Contacts
CONTACTGuo-Qing Jiang, MD
CONTACTDou-Sheng Bai, MD
STUDY_CHAIRDou-Sheng Bai
Clinical Medical College, Yangzhou University
Outcome results
None listed