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Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function

Recruitingn/aAges 18 Years - 80 YearsAllNorthern Jiangsu People's Hospital
NCT07811687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ye

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Clinical Medical College of Yangzhou University
Yangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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