Using a new method of indocyanine green for liver surgery imaging
Application of Indocyanine Green(ICG)@Human Serum Albumin(HSA) Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection: A Prospective, Double-Blinded, Randomized Controlled Trial
This study is testing a new way of using a special dye during liver surgery to see if it helps doctors find tumors better compared to the usual method, and it's for patients with liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06219096 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-75 with primary liver malignancies who are scheduled for laparoscopic anatomical liver resection and have a Child-Pugh grade A or B liver function.
Not a fit: Patients with severe liver dysfunction, coagulation disorders, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by providing better visualization of liver tumors, potentially leading to more effective resections.
How similar studies have performed: Other studies have shown promising results with similar fluorescence imaging techniques, but this specific approach using ICG-albumin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Hong Wu, Professor
- Email: wuhong@scu.edu.cn
- Phone: 18980601958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.