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New treatment option for Malignant Tumor of Liver
Official title Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection
ClinicalTrials.gov ID: NCT06219096
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- No obvious ischemic demarcation line after intraoperative occlusion or disconnection of target hepatic pedicle, or the liver fluorescence reaches an...
- 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;
See the full eligibility criteria
- 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)...
- Patients voluntarily participate and sign informed consent.
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.