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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Hepatectomy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gregor A. Stavrou, MD; Phone Number: 0049681963 2441; Email: gstavrou@klinikum-saarbruecken.de

Study Locations

• Germany
  • Saarland
    • Saarbrücken, Saarland, Germany, 66119
      • Recruiting
      • Klinikum Saarbrücken
      • Contact: Gregor A. Stavrou, Dr. Dr. habil; Phone Number: 00496819632441; Email: gstavrou@klinikum-saarbruecken.de
      • Contact: Omid Ghamar Nejad, MD; Phone Number: 00496819632441; Email: oghamar@klinikum-saarbruecken.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with any type of liver tumor undergoing 4K laparoscopic hepatectomy using indocyanine green

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor localization	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remnant liver venous drainage		One day
Detection of resection plane		One day
Rate of intraoperative bile leak	Using indocyanine green and fluorescence camera	One day
Rate of postoperative bile leak	Based on the ISGLS criteria	Three months
Resection margin	Using fluorescence camera	One day
Rate of morbidity	Based on the Clavien-Dindo classification	Three months
Duration of hospital stay		Three months
Rate of mortality	All cause death events	Three months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Indocyanine green; Tumor localization; Bile Leak; Ultra-high-definition
• Other Study ID Numbers: 26/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No