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

NCT05750329 | Not Yet Recruiting

• 1 other identifier: Renji-LT-2022-0001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 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

Keywords

liver transplantation; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Three-year overall survival rate after surgery

  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.

  3 years after the second liver resection

Secondary Outcomes (1)

• Postoperative tumor-free survival period

  3 years after the second liver resection

Study Arms (1)

Surgical group

EXPERIMENTAL

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

Interventions

assisted liver transplantation combined with two-stage hepatectomy PROCEDURE

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

Surgical group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75 years;
• 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;
• patients with end-stage liver disease;
• preoperative Child classification of A or B, able to tolerate the subsequent surgical program
• 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

You may not qualify if:

• Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration
• Tumor progression during chemotherapy or important comorbidities that affect surgery
• Uncorrectable cardiopulmonary disease with high surgical risk
• Anatomical abnormalities that preclude liver transplantation
• Persistent non-compliance with medical care
• Combined with other diseases such as AIDS that affect surgery or tumor progression

Sponsors & Collaborators

• RenJi Hospital: lead
• The Affiliated Hospital of Qingdao University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

MeSH Terms

Conditions

Liver Neoplasms; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 1, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2023

Record last verified: 2023-08