OncoMatch/Clinical Trials/NCT07811687
Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
Official title: Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function in Patients With Hepatocellular Carcinoma and Cirrhotic Hypersplenism: A Prospective Observational Cohort Study
Is NCT07811687 recruiting? Yes, currently enrolling (Oct 2026).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Demographics
Prior therapy
Cannot have received: hepatectomy
Prior history of hepatectomy
Cannot have received: splenectomy
Prior history of splenectomy
Cannot have received: other abdominal surgery precluding safe performance of laparoscopic hepatectomy combined with splenectomy
prior other abdominal surgery that precludes safe performance of laparoscopic hepatectomy combined with splenectomy
Lab requirements
Blood counts
preoperative platelet count (Plt) < 80 × 10⁹/L
Liver function
Liver function Child-Pugh class A or B, with ICG-R15 test indicating tolerance for the planned surgical resection
Cardiac function
Severe cardiac dysfunction [excluded]
Liver function Child-Pugh class A or B, with ICG-R15 test indicating tolerance for the planned surgical resection; preoperative platelet count (Plt) < 80 × 10⁹/L; Severe cardiac, pulmonary, or cerebrovascular dysfunction [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07811687 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hepatectomy, splenectomy, other abdominal surgery precluding safe performance of laparoscopic hepatectomy combined with splenectomy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages