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Trial Title:
Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer , Metastases or Emd-stage Liver Disease (LTLR-LC)
NCT ID:
NCT05750329
Condition:
Liver Transplant Disorder
Hepatic Cancer
End-stage Liver Disease
Conditions: Official terms:
Liver Neoplasms
Liver Diseases
End Stage Liver Disease
Conditions: Keywords:
liver transplantation
Hepatectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All enrolled patients received 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
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
assisted liver transplantation combined with two-stage hepatectomy
Description:
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
Arm group label:
Surgical group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. aged 18-75 years;
2. patients with unresectable primary hepatocellular carcinoma or colorectal cancer
with liver metastases who also meet the following criteria: tumor shrinkage (still
unresectable) or no significant progression after a first-line chemotherapy regimen
of 6-8 weeks; no other abdominal metastases or 1-3 resectable pulmonary metastases;
3. patients with end-stage liver disease;
4. preoperative Child classification of A or B, able to tolerate the subsequent
surgical program
5. Signed informed consent Note: One of the second or third criteria needs to be
fulfilled and all the rest of the selection criteria need to be fulfilled
Exclusion Criteria:
1. Extrahepatic tumor burden (except for resectable lung metastases) and/or
macrovascular tumor infiltration
2. Tumor progression during chemotherapy or important comorbidities that affect surgery
3. Uncorrectable cardiopulmonary disease with high surgical risk
4. Anatomical abnormalities that preclude liver transplantation
5. Persistent non-compliance with medical care
6. Combined with other diseases such as AIDS that affect surgery or tumor progression
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2023
Completion date:
December 2026
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05750329
