Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNorthern Jiangsu People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years, both male and female.
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.
Liver cirrhosis with splenomegaly and hypersplenism, and preoperative platelet count (Plt) < 80 × 10⁹/L.
Liver function Child-Pugh class A or B, with ICG-R15 test indicating tolerance for the planned surgical resection.
Disqualifiers
Imaging evidence of extrahepatic metastasis or major vascular invasion (portal vein, hepatic vein); or concurrent other malignancy within the past 5 years.
End-stage liver cirrhosis (Child-Pugh class C).
Prior history of hepatectomy or splenectomy; or prior other abdominal surgery that precludes safe performance of laparoscopic hepatectomy combined with splenectomy.
Cirrhosis-related complications (hepatic encephalopathy, refractory ascites) occurring within 1 month before surgery.
Trial population
This is a 2-year prospective, single-center, observational cohort study. Patients diagnosed with hepatocellular carcinoma (HCC) complicated with cirrhotic hypersplenism, who are scheduled to undergo elective laparoscopic hepatectomy combined with splenectomy, will be enrolled and followed for 2 years to evaluate the dynamic changes in hepatic functional reserve (assessed by ICG-R15, Child-Pugh score, and ALBI grade) and immune function (peripheral blood lymphocyte subsets including CD4⁺/CD8⁺ T cells, Tregs, NK cells, B cells, and serum cytokine profiles). Assessments will be performed at baseline and at 3, 6, 12, 18, and 24 months post-surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in Hepatic Functional Reserve (ICG-R15)
Comparison of changes in indocyanine green retention rate at 15 minutes (ICG-R15) from baseline to 3、6、12、18、24 months post-surgery.
Time frame
Baseline, 3、6、12、18、24 months post-surgerySecondary outcomes
1
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines
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.
Time frame
At 3, 6, 12, 18 and 24 months after surgery2
Hepatocellular Carcinoma (HCC) Recurrence Rate
Intrahepatic and extrahepatic recurrence confirmed by contrast-enhanced CT or MRI, calculating the cumulative recurrence rates at 12 and 24 months after surgery.
Time frame
At 12 and 24 months after surgery3
Overall Survival (OS)
Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.
Time frame
12、24 months after surgery4
Recurrence-Free Survival (RFS)
Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method.
Time frame
12、24 months after surgerySponsors and contacts
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Source ClinicalTrials.gov