Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study.

Mammalian target of rapamycin (mTOR) inhibitor as an attractive drug target with promising antitumor effects has been widely investigated. High quality clinical trial has been conducted in liver transplant (LT) recipients in Western countries. However, the pertinent studies in Eastern world are paucity. Therefore, we designed a clinical trial to test whether sirolimus can improve recurrence-free survival (RFS) in hepatocellular carcinoma (HCC) patients beyond the Milan criteria after LT. This is an open-labeled, single-arm, prospective, multicenter, and real-world study aiming to evaluate the clinical outcomes of early switch to sirolimus-based regimens in HCC patients after LT. Patients with a histologically proven HCC and beyond the Milan criteria will be enrolled. The initial immunosuppressant regimens are center-specific for the first 4-6 weeks. The following regimens integrated sirolimus into the regimens as a combination therapy with reduced calcineurin inhibitors based on the condition of patients and centers. The study is planned for 4 years in total with a 2-year enrollment period and a 2-year follow-up. We predict that sirolimus conversion regimen will provide survival benefits for patients particular in the key indicator RFS as well as better quality of life. If the trial is conducted successfully, we will have a continued monitoring over a longer follow-up time to estimate indicator of overall survival. We hope that the outcome will provide better evidence for clinical decision-making and revising treatment guidelines based on Chinese population data. Trial register: Trial registered at http://www.chictr.org.cn: ChiCTR2100042869.

Pancreaticoduodenectomy assisted by 3-D visualization reconstruction and portal vein arterialization: A case report (a CARE-compliant article).

BACKGROUND: Three-dimensional visualization reconstruction, the 3-D visualization model reconstructed by software using 2-D CT images, has been widely applied in medicine; but it has rarely been applied in pancreaticoduodenectomy. Although the hepatic artery is very important for the liver, it has to be removed when tumor invades it. Therefore, portal vein arterialization has been used in clinic as a remedial measure, but there still is professional debate on portal vein arterialization. METHODS: Here, we report 1 case that was diagnosed with poorly differentiated adenocarcinoma of the duodenum. The tumor had large size and invaded surrounding organs and vessels. RESULTS: Preliminary diagnoses were poorly differentiated adenocarcinoma of the duodenum and viral hepatitis B. Pancreaticoduodenectomy assisted by 3-D visualization reconstruction and portal vein arterialization were performed in this case. The tumor was removed. Liver function returned to normal limits 1 week after operation. Digital subtraction arteriography showed compensatory artery branches within the liver 1 month after operation. CONCLUSION: 3-D visualization reconstruction can provide a reliable assistance for the accurate assessment and surgical design before pancreatoduodenectomy, and it is certainly worth adopting portal vein arterialization when retention of hepatic artery is impossible or conventional arterial anastomosis is required during pancreatoduodenectomy.