NCT07811687Recruiting
Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- 2 Aug 2026
- Primary completion date
- 20 Jul 2029
- Lead sponsor
- Northern Jiangsu People's Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07811687
What you commit to
- Study type: Observational
- Planned participants: 30
- From 2 Aug 2026 to the primary completion date, 20 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Imaging evidence of extrahepatic metastasis or major vascular invasion (portal vein, hepatic vein); or concurrent other malignancy within the past 5 years.
- 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.
Other illness
- Severe cardiac, pulmonary, or cerebrovascular dysfunction.
- Active infection or underlying disease requiring immunosuppressive therapy.
Other
- End-stage liver cirrhosis (Child-Pugh class C).
- Pregnancy or lactation.
- Poor compliance, unable to complete the scheduled follow-up
Who the study is looking for
- 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.
- Voluntarily sign written informed consent.
- Able to complete 24-month follow-up.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Medical College of Yangzhou University Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.