SALT for Liver Cirrhosis With HCC

NCT06069947 | Not Yet Recruiting

• 1 other identifier: LY2023-185-C
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

HCC is the third leading cause of cancer deaths worldwide. Although surgical treatment may be effective in patients with HCC, the five-year survival rate is only 50-70%. Moreover, due to the lack of early diagnostic marker, most patients with HCC are often diagnosed in an advanced stage with poor prognosis. Therefore, there is an urgent need to further understand the possible aetiological factors and surgical treatment methods to improve the prognosis of patients with HCC. Liver transplantation is an ideal choice for patients with liver cirrhosis with HCC, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of patients with liver cirrhosis with HCC. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.

Conditions

HCC; Liver Cirrhosis

Keywords

Hepatocellular Carcinoma; Liver cirrhosis; Liver transplantation; Two-stage liver resection

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  To describe overall survival in patients with liver cirrhosis with HCC treated with sequential adult left lateral lobe liver transplantation.

  3 years after the second liver resection

Secondary Outcomes (1)

• Disease-free survival，DFS

  1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplant

Study Arms (1)

Surgical group

EXPERIMENTAL

SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.

Procedure: sequential adult left lateral lobe liver transplantation (SALT)

Interventions

sequential adult left lateral lobe liver transplantation (SALT) PROCEDURE

Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.

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:

• Age 18-75;
• Child-Pugh A-B ;
• liver cirrhosis with Heoatocellular Carcinoma (HCC) with Hepatitis B virus infection 4. Patients with Heoatocellular Carcinoma (HCC) meets the "up to seven" criteria: the sum of tumour size and tumour numbers does not exceed 7;
• \. Performance Status 0-1; 6. Sign the informed consent form.

You may not qualify if:

• Combined with the main portal vein tumor thrombus, the main vena cava tumor thrombus and common bile duct tumor thrombus;
• Combined with severe hepatic encephalopathy ;
• Combined with pulmonary hypertension(high-risk or middle-risk, WHO grade: III-IV);
• Special types of anatomical variations(such as portal vein classification: type III and type IV, etc. );
• Extrahepatic tumor burden;
• Cardiopulmonary disease or severe infection or Cerebral Vascular Disease that cannot be corrected, with high surgical risk, that makes liver transplantation impossible;
• Psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;
• Other reasons that the researchers think are not suitable for participation.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

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: SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 6, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share