HCC - Hepatocellular Carcinoma, Hypersplenism, Liver Cirrhosis
Conditions
Keywords
Laparoscopic Hepatectomy, Laparoscopic Splenectomy, Hepatic Functional Reserve, Hepatic Immune Function, Hepatocellular Carcinoma, Cirrhotic Hypersplenism
Brief summary
Splenectomy may relieve hypersplenism, reverse liver fibrosis, improve hepatic functional reserve, and reshape the systemic antitumor immune milieu by removing the source of negative immunomodulation. This prospective cohort study aims to enroll patients undergoing laparoscopic hepatectomy combined with splenectomy for small hepatocellular carcinoma（HCC） with a preoperative platelet count \<80×10\^9/L. The study will evaluate the dynamic changes in hepatic functional reserve, immune function, and risk of HCC recurrence through five post-surgical time points（3, 6, 12, 18, and 24 months after surgery）. The endpoints include hepatic functional reserve（ICG-R15, Child-Pugh score, ALBI score, etc.）, immune function indicators（peripheral blood lymphocyte subsets: CD4\^+ T cells, CD8\^+ T cells, regulatory T cells, NK cells, etc., and serum cytokine profiles）, and HCC recurrence rate within 2 years after surgery（confirmed by imaging）. This trial will provide evidence to optimize surgical strategies for patients with small HCC complicated with hypersplenism.
Detailed description
This is a single-center, prospective, observational cohort study. The primary outcome is hepatic functional reserve（ICG-R15） at 12 and 24 months post-surgery. Secondary outcomes include peripheral blood lymphocyte subsets（CD4\^+ T, CD8\^+ T, Treg, NK cells）, serum cytokines, and HCC recurrence rates at 12 and 24 months（confirmed by contrast-enhanced CT/MRI）. All participants will undergo scheduled follow-up visits at 3, 6, 12, 18, and 24 months post-surgery. Written informed consent will be obtained from all participants before surgery. The study protocol has been approved by the Institutional Ethics Committee.
Interventions
None listed
Sponsors
Northern Jiangsu People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, both male and female. 2. Hepatocellular carcinoma (HCC) confirmed by clinical, pathological, and radiological examinations, meeting either of the following criteria:Solitary tumor with maximum diameter ≤ 5 cm; or Multiple tumors (≤ 3 in number), each with maximum diameter ≤ 3 cm. 3. Liver cirrhosis with splenomegaly and hypersplenism, and preoperative platelet count (Plt) \< 80 × 10⁹/L. 4. Liver function Child-Pugh class A or B, with ICG-R15 test indicating tolerance for the planned surgical resection. 5. Voluntarily sign written informed consent. 6. Able to complete 24-month follow-up.
Exclusion criteria
1. Imaging evidence of extrahepatic metastasis or major vascular invasion (portal vein, hepatic vein); or concurrent other malignancy within the past 5 years. 2. End-stage liver cirrhosis (Child-Pugh class C). 3. Prior history of hepatectomy or splenectomy; or prior other abdominal surgery that precludes safe performance of laparoscopic hepatectomy combined with splenectomy. 4. Cirrhosis-related complications (hepatic encephalopathy, refractory ascites) occurring within 1 month before surgery. 5. Severe cardiac, pulmonary, or cerebrovascular dysfunction. 6. Active infection or underlying disease requiring immunosuppressive therapy. 7. Pregnancy or lactation. 8. Poor compliance, unable to complete the scheduled follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hepatic Functional Reserve (ICG-R15) | Baseline, 3、6、12、18、24 months post-surgery | Comparison of changes in indocyanine green retention rate at 15 minutes (ICG-R15) from baseline to 3、6、12、18、24 months post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines | At 3, 6, 12, 18 and 24 months after surgery | Dynamic assessment of peripheral blood T cell subsets (CD4+/CD8+ ratio and absolute counts), regulatory T cells (Treg), natural killer (NK) cells, B cells, and serum cytokine profiles (IL-2, IL-6, TNF-α, IFN-γ, etc.) to evaluate postoperative immune reconstitution patterns. |
| Hepatocellular Carcinoma (HCC) Recurrence Rate | At 12 and 24 months after surgery | Intrahepatic and extrahepatic recurrence confirmed by contrast-enhanced CT or MRI, calculating the cumulative recurrence rates at 12 and 24 months after surgery. |
| Overall Survival (OS) | 12、24 months after surgery | Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method. |
| Recurrence-Free Survival (RFS) | 12、24 months after surgery | Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method. |
Countries
China
Contacts
CONTACTGuo-Qing Jiang, MD
CONTACTDou-Sheng Bai, MD
STUDY_CHAIRGuo-Qing Jiang
Clinical Medical College of Yangzhou University
Outcome results
None listed