Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection

This study is a single-center, prospective, randomized controlled trial that aims to compare the efficacy and safety of a new indocyanine green (ICG) administration protocol with the current guideline-recommended protocol for near-infrared (NIR) fluorescence imaging in laparoscopic anatomical hepatic resection. Primary liver cancer is a common malignancy worldwide. Laparoscopic liver resection has become increasingly popular due to its minimally invasive nature. During open and laparoscopic liver resection surgery, ICG, a fluorescent dye, is widely used to visualize liver segments and define tumor margins. However, there is a lack of high-level evidence regarding the timing and dosage of ICG administration in current protocols. In our preliminary study, we discovered a new method of pre-mixing ICG with albumin, which creates a more stable conjugate that could enhance fluorescence imaging during NIR laparoscopic hepatectomy. This study will include 100 patients with primary liver malignancies who are scheduled for laparoscopic anatomical hepatic resection. The patients will be randomly assigned in a 1:1 ratio to either the new ICG-albumin protocol (experimental group) or the standard ICG alone protocol (control group). The primary outcome will be the efficacy of fluorescence imaging, which will be evaluated using a 5-point scoring system by three independent experts. Secondary outcomes will include operation time, blood loss, tumor margin status, complications, length of stay, long-term recurrence, and survival. The hypothesis of this study is that pre-binding ICG with albumin creates a more stabilized fluorescent complex, which could significantly improve the efficacy of fluorescence navigation and hepatectomy outcomes compared to standard ICG alone. This study aims to provide high-quality evidence on optimal protocols for ICG use in laparoscopic fluorescent image-guided liver surgery. The results of this study could help establish standardized guidelines to improve the application of this important navigation technique and enhance surgical precision and outcomes for liver cancer patients worldwide. The study protocol will be approved by the Ethics Review Board and publicly registered before enrollment starts. All participants will be required to provide informed consent. This study will be conducted in compliance with the Declaration of Helsinki and national regulations on human subject protection to ensure ethics, privacy, and safety.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Age: 18-75 years old, patients with hepatic malignancies who are undergoing laparoscopic anatomical liver resection;
2. Preoperative liver function Child-Pugh grade A or B;
3. No contraindications for laparoscopic liver resection;
4. Expected survival ≥3 months;
5. ECOG PS score 0-1;
6. Normal major organ functions, and meet the following laboratory test results within 7 days prior to enrollment: white blood cell (WBC) ≥2.5×10\^9/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet (PLT) ≥75×10\^9/L, hemoglobin (HGB) ≥90g/L; NR ≤1.5xULN; serum creatinine (CT) ≤1.5xULN; total bilirubin (TBI) ≤1.5×upper limit of normal (ULN);
7. Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

1. No obvious ischemic demarcation line after intraoperative occlusion or disconnection of target hepatic pedicle, or the liver fluorescence reaches an intensity that interferes with surgery before intraoperative ICG injection.
2. Poor hepatic reserve function (ICG R15 ≥ 20%);
3. Severe cardiopulmonary diseases, intolerant to general anesthesia and surgery;
4. Moderate or large amount of symptomatic ascites or pleural effusion;
5. Active bleeding or coagulation abnormalities;
6. Hepatic encephalopathy;
7. Allergy to ICG;
8. History of gastrointestinal bleeding within the past 6 months or definite tendency for gastrointestinal bleeding;
9. Severe esophageal gastric varices requiring interventional treatment;
10. Objective evidence showing severe impaired pulmonary function such as pulmonary fibrosis;
11. Any significant clinical and laboratory abnormalities that the investigator considers affecting safety assessment.

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