Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07461532
Brief Summary:
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis at one year and long-term follow-up in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection.
Detailed Description:
After successful screening, liver cirrhotic patients of any etiology without portal vein thrombosis will be enrolled. From postoperative day 1, patients in the apixaban group will receive oral apixaban 2.5 mg twice daily for six months as monotherapy. Doppler ultrasound screening for portal vein thrombosis (PVT) or spleno-mesenteric thrombosis will be performed for all patients at baseline, on postoperative day 7 (POD 7), and at postoperative months 1, 3, 6, 12, 18, 24, and 36 (POM 1, 3, 6, 12, 18, 24, 36). All patients will complete the six-month prophylactic therapy regardless of Doppler findings regarding PVT occurrence. After the six-month treatment period, patients will be evaluated and will discontinue therapy to enter the monitoring phase. Long-term follow-up will continue up to 36 months to evaluate the primary outcome of PVT treatment effect and secondary outcomes including portal hypertension progression, rebleeding rates, hepatic encephalopathy, and survival.
Study:
NCT07461532
Study Brief:
Protocol Section:
NCT07461532