Apixaban for portal vein thrombosis occurring more than one year after laparoscopic splenectomy and azygoportal disconnection

Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection

This trial will try whether taking apixaban 2.5 mg twice daily can treat portal vein clots that appear more than a year after laparoscopic splenectomy and azygoportal disconnection in people with cirrhosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07461532 on ClinicalTrials.gov

What this trial studies

This interventional protocol gives oral apixaban 2.5 mg twice daily to patients who develop portal vein thrombosis more than 12 months after laparoscopic splenectomy and azygoportal disconnection. Efficacy and clot status are monitored every three months using Doppler ultrasound or contrast-enhanced CT. Patients who show improvement on imaging continue apixaban, while safety monitoring focuses on bleeding and liver-related adverse events. Eligible participants are those operated on at the enrolling center who had no thrombosis in the first postoperative year and consent to serial imaging follow-up.

Who should consider this trial

Good fit: Adults with cirrhosis who underwent laparoscopic splenectomy and azygoportal disconnection at the enrolling center, had no portal vein thrombosis during the first postoperative year, and then developed thrombosis after 12 months.

Not a fit: Patients who develop portal vein thrombosis within the first postoperative year, those with contraindications to anticoagulation or active bleeding, or patients treated elsewhere without required baseline imaging are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If effective, apixaban could restore portal vein blood flow or prevent clot progression with a convenient oral regimen, potentially reducing complications from portal vein thrombosis.

How similar studies have performed: Small observational studies and case series of direct oral anticoagulants, including apixaban, have reported promising recanalization rates for portal vein thrombosis in cirrhosis, but randomized controlled data remain limited.

Eligibility criteria

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

Where this trial is running

Yangzhou, Jiangsu

• Clinical Medical College — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Guo-Qing Jiang, MD

Conditions Cirrhosis; Splenectomy; Portal Vein Thrombosis; Hypertension, Portal; Portal Hypertension; Apixaban; Laparoscopy; Hypersplenism