Laparoscopic liver and spleen removal for small liver cancer in people with cirrhosis and enlarged spleen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational cohort study of patients with cirrhosis, hypersplenism, and small hepatocellular carcinoma undergoing laparoscopic hepatectomy with splenectomy. The primary outcome is hepatic functional reserve measured by ICG-R15 at 12 and 24 months post-surgery. Secondary outcomes include changes in peripheral lymphocyte subsets, serum cytokines, and the rate of HCC recurrence within 12 and 24 months, assessed by imaging. Participants are evaluated at 3, 6, 12, 18, and 24 months after surgery, with informed consent and ethics approval in place.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Medical College of Yangzhou University
  Yangzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Guo-Qing Jiang, MD
• Email: jgqing2003@hotmail.com
• Phone: +8651487373272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.