Using a new method of indocyanine green for liver surgery imaging

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 clinical trial is a single-center, prospective, randomized controlled trial comparing a novel indocyanine green (ICG) administration protocol with the standard protocol for fluorescence imaging during laparoscopic anatomical liver resection. The study will enroll 100 patients aged 18-75 with primary liver malignancies, randomly assigning them to either the experimental group using the new ICG-albumin protocol or the control group using the standard ICG protocol. The primary outcome will assess the efficacy of fluorescence imaging through a scoring system evaluated by independent experts. The goal is to enhance visualization of liver segments and tumor margins during surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Hong Wu, Professor
• Email: wuhong@scu.edu.cn
• Phone: 18980601958

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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.