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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

NCT ID NCT07811687

NEW Sponsor: Northern Jiangsu People's Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatocellular carcinoma hypersplenism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCC - hepatocellular carcinoma Hypersplenism Liver cirrhosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Medical College of Yangzhou University

    RECRUITING

    Yangzhou, Jiangsu, 225001, China

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