Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer or Metastases (LTLR-LC)
Study Details
Study Description
Brief 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.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 or colorectal cancer liver metastases. By improvement of RAPID operation, the safety and efficacy of this treatment method in patients with unresectable primary liver cancer or colorectal cancer liver metastases were evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Surgical group All patients underwent left hepatectomy combined with orthotopic S2-3 liver segment transplantation, and then underwent autologous right hepatectomy after the graft had grown sufficiently large. |
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
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Outcome Measures
Primary Outcome Measures
- Three-year overall survival rate after surgery [3 years after the second liver resection]
After the second liver resection, patients were followed up through outpatient clinics and telephone (interval: once a month for a total of three years). The end point of follow-up was the death of the patient or survival after three years of follow-up. After reaching the end point of follow-up, the overall survival rate was analyzed by drawing survival curves.
Secondary Outcome Measures
- Postoperative tumor-free survival period [3 years after the second liver resection]
After the second liver resection, regular follow-up of patients' serological and imaging indicators: Serological indicators include tumor markers, such as AFP, AFP heterogeneity, CEA, CA19-9, etc., imaging Medical indicators include abdominal ultrasound, enhanced CT, enhanced magnetic resonance or PET-CT examination. Serological examination and B-ultrasound examination should be performed once a month for the first year after surgery, and once every three months for the next two years. Enhanced CT or enhanced MRI should be performed at the 1st, 3rd, and 6th months after operation, and then once every six months (if the serology or B-ultrasound examination indicates abnormalities, an additional examination will be performed). Two or more imaging examinations diagnosed as malignant tumors were considered as tumor recurrence. Tumor recurrence or no recurrence after three years of follow-up was used as the end point of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with unresectable primary liver cancer or liver metastases from colorectal cancer, first-line chemotherapy for 6-8 weeks after diagnosis, tumor shrinkage or no obvious progression;
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No other abdominal metastasis except the liver or there are 1-3 resectable lung metastases;
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Child grade A or B preoperatively, able to tolerate subsequent surgical options
Exclusion Criteria:
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Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration
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Tumor progression during chemotherapy or important comorbidities that affect surgery
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Uncorrectable cardiopulmonary disease with high surgical risk
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Anatomical abnormalities that preclude liver transplantation
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Persistent non-compliance with medical care
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Combined with other diseases such as AIDS that affect surgery or tumor progression
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RenJi Hospital
- The Affiliated Hospital of Qingdao University
- The First Affiliated Hospital of Zhengzhou University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Renji-LT-2022-0001