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临床试验/NCT04946591
NCT04946591已完成不适用

Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection: A Single-centre Prospective Study

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Tumor localization

研究概览

简要总结

Achievement of tumor-free resection margin with the largest possible remnant liver parenchyma is the major challenge in hepatic surgery. Therefore, perioperative tumor detection, anatomical mapping of liver segments and also nearby structures are vital to improve the short- and long-term surgical outcomes. Over last decades, several real-time methods have been introduced for this purpose. These methods are mostly based on the utilizing of traceable dyes, which are excreted into the biliary tract. With the advances in minimal invasive surgery and video technology, indocyanine green became the most used dye in this manner. It has been demonstrated that using indocyanine green, small liver tumors can be detected, which cannot be identified using conventional intraoperative methods. Based on the literature, the reported sensitivity of tumor detection using indocyanine green is ranging between 98%-100%, while conventional methods could not reach 90% sensitivity. Posthepatectomy bile leakage, as well as in- or outflow distributions due to the potential vascular reconstructions, are some of the most common complications that can occur especially after complex liver surgeries. Beside the abovementioned advantages of indocyanine green, several researchers have also shown the feasibility of indocyanine green to identify the intraoperative bile leaks and any in- or outflow distributions. Nevertheless, laparoscopic assisted liver surgery is technically challenging, mostly because of the restricted degrees of instrument movements, camera instability, and loss of depth perception. In particular, the loss of depth perception and inaccurate object localization can lead to intraoperative complications and a long learning curve. Advances in video technology, namely 4K ultra-high-definition imaging have been developed to reduce perioperative complications and to shorten the learning curve during laparoscopic liver surgery. This is the first prospective study evaluating the impact of indocyanine green imaging during 4K laparoscopic liver surgery on real-time tumor detection and surgical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consent
  • Aged above 18 years
  • Undergoing any type of liver resections

排除标准

  • Unresectable liver tumors
  • Known indocyanine green allergy
  • Iodine allergy
  • Advanced cirrhosis (Child C)

结局指标

主要结局

Tumor localization

时间窗: One day

次要结局

  • Rate of intraoperative bile leak(One day)
  • Detection of resection plane(One day)
  • Duration of hospital stay(Three months)
  • Rate of postoperative bile leak(Three months)
  • Rate of mortality(Three months)
  • Resection margin(One day)
  • Rate of morbidity(Three months)
  • Remnant liver venous drainage(One day)

研究者

发起方
Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.med Dr. habil Gregor A. Stavrou

Head of the Department

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

研究点 (1)

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