Light-absorbing properties, stability, and spectral stabilization of indocyanine green.
M L Landsman, G Kwant, G A Mook...
https://pubmed.ncbi.nlm.nih.gov/776922Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06219096
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
Led by West China Hospital · Updated on 2024-01-23
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
W
West China Hospital
Lead Sponsor
N
Nanjing Chia-Tai Tianqing Pharmaceutical Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new method to improve imaging during laparoscopic anatomical liver resection in patients with primary liver cancer. This randomized, double-blinded trial compares a novel protocol that mixes indocyanine green (ICG) with human serum albumin (HSA) to the standard ICG protocol. The study aims to provide better evidence on how to optimize ICG use for clearer fluorescence imaging, which may help surgeons define liver segments and tumor margins more precisely during surgery. Participants will be randomly assigned to one of two groups. The experimental group receives an intravenous infusion of the ICG-albumin complex after ligation of the target hepatic portal vein, while the control group receives a standard bolus injection of ICG alone. The infusion in the experimental group is given slowly until sufficient fluorescence is observed. This study includes a screening period before surgery and follow-up visits scheduled up to 36 months post-surgery. During the study, patients will be monitored closely with assessments including a 5-point fluorescence imaging score by independent experts as the primary outcome. Secondary outcomes include operation time, blood loss, tumor margin status, complications, liver function recovery, and long-term recurrence and survival. Safety is monitored by reporting adverse reactions and complications. Data collection and analysis will help determine if the new protocol can improve surgical precision and outcomes. The total participation time includes screening, surgery, hospitalization, and long-term follow-up visits.
CONDITIONS
Brief Title
Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of hepatic malignancies scheduled for laparoscopic anatomical liver resection
- Preoperative liver function Child-Pugh grade A or B
- No contraindications for laparoscopic liver resection
- Expected survival of 3 months or more
- ECOG performance status score of 0 or 1
- Normal major organ functions and laboratory tests within 7 days before enrollment including WBC 2.5x10^9/L, ANC 1.5x10^9/L, PLT 75x10^9/L, HGB 90g/L, normal renal and liver function
- Voluntary participation with signed informed consent
You will not qualify if you...
- No clear ischemic demarcation line after occlusion of target hepatic pedicle or interfering liver fluorescence before ICG injection
- Poor liver reserve function with ICG R15 20%
- Severe heart or lung diseases making general anesthesia or surgery intolerable
- Moderate or large symptomatic ascites or pleural effusion
- Active bleeding or coagulation disorders
- Hepatic encephalopathy
- Allergy to indocyanine green (ICG)
- History of gastrointestinal bleeding within past 6 months or high risk of bleeding
- Severe esophageal or gastric varices requiring intervention
- Severe impaired lung function such as pulmonary fibrosis
- Any significant clinical or laboratory abnormalities affecting safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 2 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day
Participants undergo laparoscopic anatomical liver resection using either the novel ICG@HSA complex or the standard ICG protocol for fluorescence image guidance during surgery.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 4 weeks after surgery
Participants are followed during hospitalization for recovery and monitored for postoperative complications and liver function recovery.
Hospitalization visits plus 1 visit at 4 weeks post-surgery
Long-term Monitoring
Duration - Up to 36 months after surgery
Participants attend scheduled follow-up visits to monitor health status, recurrence, and survival after surgery.
Visits at months 1, 3, 6, 12, 18, 24, 30, and 36 post-surgery
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 614000
Actively Recruiting
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Research Team
H
Hong Wu, Professor
Q
QingYun Xie, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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Takeaki Ishizawa, Akio Saiura, Norihiro Kokudo
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Xiaoying Wang, Catherine S C Teh, Takeaki Ishizawa...
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Giammauro Berardi, Kazuharu Igarashi, Chao Jen Li...
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Taiga Wakabayashi, Andrea Benedetti Cacciaguerra, Yuta Abe...
https://pubmed.ncbi.nlm.nih.gov/35121701Application Effect of ICG Fluorescence Real-Time Imaging Technology in Laparoscopic Hepatectomy.
Hao Chen, Yumin Wang, Zhiguo Xie...
https://pubmed.ncbi.nlm.nih.gov/35463377Clinical effects of the use of the indocyanine green fluorescence imaging technique in laparoscopic partial liver resection.
Shinji Itoh, Takahiro Tomiyama, Akinari Morinaga...
https://pubmed.ncbi.nlm.nih.gov/36091307Short- and Long-Term Outcomes of Indocyanine Green Fluorescence Navigation- Versus Conventional-Laparoscopic Hepatectomy for Hepatocellular Carcinoma: A Propensity Score-Matched, Retrospective, Cohort Study.
Fusheng Liu, Haitao Wang, Weijie Ma...
https://pubmed.ncbi.nlm.nih.gov/36645540Does Using Indocyanine Green Fluorescence Imaging for Tumors Help in Determining the Safe Surgical Margin in Real-Time Navigation of Laparoscopic Hepatectomy? A Retrospective Study.
Xinran Cai, Haijie Hong, Wei Pan...
https://pubmed.ncbi.nlm.nih.gov/36484905Laparoscopic anatomical liver resection guided by real-time indocyanine green fluorescence imaging: experience and lessons learned from the initial series in a single center.
Yinzhe Xu, Mingyi Chen, Xiangfei Meng...
https://pubmed.ncbi.nlm.nih.gov/32500459