NCT07811687 Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
| NCT ID | NCT07811687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northern Jiangsu People's Hospital |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-08-02 |
| Primary Completion | 2029-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-08-02 with a primary completion date of 2029-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Guo-Qing Jiang
STUDY CHAIR
Clinical Medical College of Yangzhou University
Frequently Asked Questions
Who can join the NCT07811687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07811687 currently recruiting?
Yes, NCT07811687 is actively recruiting participants. Contact the research team at jgqing2003@hotmail.com for enrollment information.
Where is the NCT07811687 trial being conducted?
This trial is being conducted at Yangzhou, China.
Who is sponsoring the NCT07811687 clinical trial?
NCT07811687 is sponsored by Northern Jiangsu People's Hospital. The principal investigator is Guo-Qing Jiang at Clinical Medical College of Yangzhou University. The trial plans to enroll 30 participants.