NCT05750329

Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer , Metastases or Emd-stage Liver Disease (LTLR-LC)

Clinical Study of Adjuvant Liver Transplantation Combined With Two-stage Hepatectomy for the Treatment of Patients With Unresectable Primary Hepatocellular Carcinoma, Colorectal Cancer With Liver Metastases, or End-stage Liver Disease: a Multicenter, Prospective, Single-arm Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Colon cancer and primary liver cancer are common malignant tumors with low survival rate worldwide, and unresectable primary liver cancer and colon cancer liver metastases have worse prognosis. End-stage liver disease is equated with advanced liver disease, liver failure and decompensated cirrhosis because they are generally irreversible. Liver transplantation is a treatment option for the above-mentioned patients and is expected to improve the prognosis of the patients, but the biggest problem faced by such patients is the shortage of donor livers. Recently, a new surgical modality, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID), can greatly alleviate these problems.Based on clinical surgical experience, our center proposes and designs a clinical study of adjuvant liver transplantation combined with two-stage hepatectomy in the treatment of patients with unresectable primary liver cancer, colorectal cancer liver metastases, or end-stage liver disease. By improvement of RAPID operation, the safety and efficacy of this treatment method in patients with those disease were evaluated.

Conditions

• Liver Transplant Disorder
• Hepatic Cancer
• End-stage Liver Disease

Interventions

Type	Name	Description
PROCEDURE	assisted liver transplantation combined with two-stage hepatectomy	Stage 1 Surgery: Left Hepatectomy, Left Lateral Graft Implantation, Portal Shunt to Graft Intermediate stage: continuous monitoring of liver function indexes and liver transplant donor volume after the first stage of surgery. Until the graft size reaches 0.8% of body weight (GBWR), or 35%-45% of the standard liver volume. Stage 2 Surgery: Residual Right Hepatectomy

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2023-03-01
• Last updated: 2023-08-07