Evidence map›Paper›PMID 39710697›Full record

ArticleTrials2024

Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial.

Qingyun Xie, Fengwei Gao, Xiaoyun Ran, Xin Zhao, Manyu Yang, Kangyi Jiang, Tianyang Mao, Jiayin Yang, Kun Li, Hong Wu

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06219096 (Application of Indocyanine Green), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06219096 narecruitingnot on this map

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

TypeinterventionalSponsorWest China HospitalRan2023 to 2028Enrolled100ConditionsMalignant Tumor of Liver, Randomized Controlled TrialArmsNIF 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
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Qingyun Xie *Liver Transplantation Center, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center of Biotherapy, Chengdu, 610041, China.
Fengwei Gao *Liver Transplantation Center, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center of Biotherapy, Chengdu, 610041, China.
Xiaoyun RanKey Laboratory of Green Chemistry and Technology of Ministry of Education, College of Chemistry, Sichuan University, Chengdu, 610041, China.
Xin Zhao *Department of Hepato-Pancreato-biliary Surgery, People's Hospital of Leshan, Leshan, 614000, China.
Manyu YangDepartment of Hepato-Pancreato-biliary Surgery, People's Hospital of Leshan, Leshan, 614000, China.
Kangyi JiangDepartment of Hepato-Pancreato-biliary Surgery, People's Hospital of Leshan, Leshan, 614000, China.
Tianyang MaoDepartment of Hepato-Pancreato-biliary Surgery, People's Hospital of Leshan, Leshan, 614000, China.
Jiayin YangLiver Transplantation Center, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center of Biotherapy, Chengdu, 610041, China.
Kun LiKey Laboratory of Green Chemistry and Technology of Ministry of Education, College of Chemistry, Sichuan University, Chengdu, 610041, China. Kli@scu.edu.cn.
Hong WuLiver Transplantation Center, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center of Biotherapy, Chengdu, 610041, China. wuhong@scu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates have limited its widespread application. To address these issues, we developed a novel ICG-human serum albumin (ICG-HSA) complex to enhance fluorescence visualization during laparoscopic anatomical liver resection.

methodsThis prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates. DISCUSSION: The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.

trial registrationClinicalTrial.gov NCT06219096. Registered on 1 December 2024.

Indexed as

Indocyanine GreenLaparoscopyLiverOptical ImagingSerum Albumin, HumanSurgery, Computer-AssistedAdolescentAdultAgedDouble-Blind MethodFemaleFluorescent DyesHepatectomyHumansLiver NeoplasmsMaleFluorescent DyesIndocyanine GreenSerum Albumin, HumanFluorescence navigationICG-HSA complexIndocyanine greenLaparoscopic liver resectionRandomized controlled trial

Identifiers

PMID39710697
PMCPMC11664937

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.