Status:
RECRUITING
Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection
Lead Sponsor:
West China Hospital
Collaborating Sponsors:
Nanjing Chia-Tai Tianqing Pharmaceutical Company
Conditions:
Malignant Tumor of Liver
Randomized Controlled Trial
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
1. Study Design: This study is designed as a single center, prospective, randomized, double-blinded, controlled trial. The participants will be randomly assigned to either the experimental group (...
Eligibility Criteria
Inclusion
- Age: 18-75 years old, patients with hepatic malignancies who are undergoing laparoscopic anatomical liver resection;
- Preoperative liver function Child-Pugh grade A or B;
- No contraindications for laparoscopic liver resection;
- Expected survival ≥3 months;
- ECOG PS score 0-1;
- 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);
- Patients voluntarily participate and sign informed consent.
Exclusion
- 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.
- Poor hepatic reserve function (ICG R15 ≥ 20%);
- Severe cardiopulmonary diseases, intolerant to general anesthesia and surgery;
- Moderate or large amount of symptomatic ascites or pleural effusion;
- Active bleeding or coagulation abnormalities;
- Hepatic encephalopathy;
- Allergy to ICG;
- History of gastrointestinal bleeding within the past 6 months or definite tendency for gastrointestinal bleeding;
- Severe esophageal gastric varices requiring interventional treatment;
- Objective evidence showing severe impaired pulmonary function such as pulmonary fibrosis;
- Any significant clinical and laboratory abnormalities that the investigator considers affecting safety assessment.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06219096
Start Date
December 10 2023
End Date
December 31 2028
Last Update
January 23 2024
Active Locations (1)
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1
West China Hospital
Chengdu, Sichuan, China, 614000