Liver surgery with spleen removal in liver cancer with an enlarged, overactive spleen
Follows liver function and immune health after combined surgery in adults with small liver cancer.
Plain-language title generated from the registry record
Registry title: Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
Key facts
- Where
- Yangzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with small liver cancer (hepatocellular carcinoma) and cirrhosis with an enlarged, overactive spleen (hypersplenism) who are having keyhole liver surgery together with spleen removal.
- Age
- 18 to 80 years
- Sex
- Men and women
- Disease stage
- Small liver cancer: one tumor up to 5 cm (2 in), or up to 3 tumors each up to 3 cm (1.2 in). Cirrhosis with enlarged spleen and hypersplenism. Liver function Child-Pugh class A or B.
- Earlier treatment
- No earlier liver surgery or spleen removal.
- Biomarker or test result
- Platelet count below 80 × 10⁹/L before surgery. The liver test ICG-R15 must show the planned surgery can be tolerated.
Main reasons for not taking part
- Cancer spread outside the liver, or invasion of major blood vessels (portal vein, hepatic vein)
- Another cancer within the past 5 years
- End-stage cirrhosis (Child-Pugh class C)
- Cirrhosis complications within 1 month before surgery (hepatic encephalopathy, refractory ascites)
- Pregnancy or breastfeeding
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07811687, who can take part
Where in China
- Clinical Medical College of Yangzhou UniversityYangzhou, ChinaContact: Guo-Qing Jiang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Northern Jiangsu People's Hospital
- Trial code
- NCT07811687
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Severe cardiac, pulmonary, or cerebrovascular dysfunction; Active infection or underlying disease requiring immunosuppressive therapy; End-stage liver cirrhosis (Child-Pugh class C); Pregnancy or lactation; Poor compliance, unable to complete the scheduled follow-up.