NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
Trial Parameters
Brief Summary
This prospective, single-arm exploratory study evaluates the feasibility and safety of a novel ICG-Cisplatin self-assembled nanoprobe (NIR-II NanoM) for fluorescence-guided surgery in patients with Hepatocellular Carcinoma (HCC). Participants will receive a transarterial injection of the nanoprobe mixed with lipiodol prior to surgery. During the subsequent laparoscopic anatomic hepatectomy, surgeons will utilize a Near-Infrared II (NIR-II) imaging system to visualize tumor boundaries and liver segments for precise resection.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years. 2. First diagnosis of Hepatocellular Carcinoma (HCC) (non-recurrent). 3. Single tumor with diameter ≤ 5 cm. 4. Assessed as resectable by more than 2 senior liver surgeons (experience \>10 years, \>500 hepatectomies). 5. No distant metastasis on preoperative chest CT and abdominal contrast-enhanced CT. 6. Child-Pugh Class A liver function. 7. Patient or legal guardian able to understand the study and sign informed consent. Exclusion Criteria: 1. Postoperative pathology confirms cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma. 2. Presence of portal vein, hepatic vein, or bile duct tumor thrombus. 3. History of other malignancies (except cured carcinoma in situ of cervix, basal cell carcinoma, or squamous cell skin carcinoma). 4. Evidence of residual lesion, recurrence, or metastasis during preoperative assessment; or postoperative pathology confirming lymph node metastasis or positive margins. 5. Moderate to severe