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Clinical Trials in China / NCT07811687
Recruiting Observational

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

NCT07811687 · tracked via the Priya Life Science China tracker
Sponsor
Northern Jiangsu People's Hospital
Phase
Observational
Started
2026-08-02
Last updated
2026-09-10

Condition(s) studied

Liver CirrhosisHCC - Hepatocellular CarcinomaHypersplenism

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Clinical Medical College of Yangzhou University Yangzhou Jiangsu Recruiting

More Northern Jiangsu People's Hospital trials in China

Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients Recruiting
The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients Recruiting
Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection Recruiting
Effect of Laparoscopic Splenectomy on Lipid Profiles in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up) Starting soon
Effect of Thread Embedding Acupuncture on Postoperative Ileus Recovery After Colorectal Cancer Surgery: A Multicenter Randomized Controlled Trial Recruiting

Other trials for the same condition

Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis Recruiting
Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma Starting soon
Sonazoid CEUS for Early HCC Surveillance Starting soon
Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer Active, not recruiting
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07811687 on ClinicalTrials.gov ↗ ← All trials in China