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Completed

NCT Number: NCT04946591

Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Tumor localization

    Time frame: One day

Secondary outcomes

  1. Remnant liver venous drainage

    Time frame: One day

  2. Detection of resection plane

    Time frame: One day

  3. Rate of intraoperative bile leak

    Time frame: One day

    Using indocyanine green and fluorescence camera

  4. Rate of postoperative bile leak

    Time frame: Three months

    Based on the ISGLS criteria

  5. Resection margin

    Time frame: One day

    Using fluorescence camera

  6. Rate of morbidity

    Time frame: Three months

    Based on the Clavien-Dindo classification

  7. Duration of hospital stay

    Time frame: Three months

  8. Rate of mortality

    Time frame: Three months

    All cause death events

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: LiverLight

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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