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

RecruitingNAAges 18 Years - 75 YearsAllWest China Hospital
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • NIF image-guided laparoscopic anatomical liver resection with the novel ICG@HSA administration
  • NIF image-guided laparoscopic anatomical liver resection with the guideline-recommended ICG administration
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Where

1 site
West China Hospital
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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