NCT06219096

Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection

Recruiting now NA Last updated 23 January 2024

What this trial tests

NA trial testing NIF image-guided laparoscopic anatomical liver resection with the novel ICG@HSA administration in Malignant Tumor of Liver in 100 participants. Currently enrolling.

Timeline

10 December 2023

Primary endpoint
31 December 2026

31 December 2028

Quick facts

Lead sponsor	West China Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	10 December 2023
Primary completion	31 December 2026
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• NIF image-guided laparoscopic anatomical liver resection with the novel ICG@HSA administration
• NIF image-guided laparoscopic anatomical liver resection with the guideline-recommended ICG administration

Conditions studied

• Malignant Tumor of Liver — all drugs for Malignant Tumor of Liver →
• Randomized Controlled Trial — all drugs for Randomized Controlled Trial →

Sponsor

West China Hospital

Who can join

Adults 18 to 75, any sex, with Malignant Tumor of Liver or Randomized Controlled Trial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Laparoscopic liver resection has become increasingly popular due to its minimally invasive nature. During open and laparoscopic liver resection surgery, ICG, a fluorescent dye, is widely used to visualize liver segments and define tumor margins. However, there is a lack of high-level evidence regarding the timing and dosage of ICG administration in current protocols. In our preliminary study, we discovered a new method of pre-mixing ICG with albumin, which creates a more stable conjugate that could enhance fluorescence imaging during NIR laparoscopic hepatectomy. This study will include 100 patients with primary liver malignancies who are scheduled for laparoscopic anatomical hepatic resection. The patients will be randomly assigned in a 1:1 ratio to either the new ICG-albumin protocol (experimental group) or the standard ICG alone protocol (control group). The primary outcome will be the efficacy of fluorescence imaging, which will be evaluated using a 5-point scoring system by three independent experts. Secondary outcomes will include operation time, blood loss, tumor margin status, complications, length of stay, long-term recurrence, and survival.

The hypothesis of this study is that pre-binding ICG with albumin creates a more stabilized fluorescent complex, which could significantly improve the efficacy of fluorescence navigation and hepatectomy outcomes compared to standard ICG alone. This study aims to provide high-quality evidence on optimal protocols for ICG use in laparoscopic fluorescent image-guided liver surgery. The results of this study could help establish standardized guidelines to improve the application of this important navigation technique and enhance surgical precision and outcomes for liver cancer patients worldwide. The study protocol will be approved by the Ethics Review Board and publicly registered before enrollment starts. All participants will be required to provide informed consent. This study will be conducted in compliance with the Declaration of Helsinki and national regulations on human subject protection to ensure ethics, privacy, and safety.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of indocyanine green-human serum albumin complexes in fluorescence image-guided laparoscopic anatomical liver resection: a case series study (with video).
   Gao F, Xie Q, Ran X, Zhao X, et al · · 2024 · cited 5× · PMID 39342539 · DOI 10.1007/s00464-024-11295-8
2. Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial.
   Xie Q, Gao F, Ran X, Zhao X, et al · · 2024 · cited 2× · PMID 39710697 · DOI 10.1186/s13063-024-08695-5
3. Application of indocyanine green–human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial
   Xie Q, Gao F, Ran X, Zhao X, et al · · 2024 · DOI 10.21203/rs.3.rs-4503575/v1