An observational study in Liver Cirrhosis, HCC - Hepatocellular Carcinoma and Hypersplenism, sponsored by Northern Jiangsu People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Northern Jiangsu People's Hospital · Observational
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.
This is a single-center, prospective, observational cohort study. The primary outcome is hepatic functional reserve（ICG-R15） at 12 and 24 months post-surgery. Secondary outcomes include peripheral blood lymphocyte subsets（CD4\^+ T, CD8\^+ T, Treg, NK cells）, serum cytokines, and HCC recurrence rates at 12 and 24 months（confirmed by contrast-enhanced CT/MRI）. All participants will undergo scheduled follow-up visits at 3, 6, 12, 18, and 24 months post-surgery. Written informed consent will be obtained from all participants before surgery. The study protocol has been approved by the Institutional Ethics Committee.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 30 is below the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Northern Jiangsu People's Hospital is the lead sponsor of 61 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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-surgery
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 surgery
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 surgery
Overall Survival (OS)
Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.
Time frame: 12、24 months after surgery
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 surgery
Started Aug 2026 (actual). Primary completion is estimated for Jul 2029, 35 months after the start.
Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 35 months is below that.
Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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Northern Jiangsu People's Hospital