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

Laparoscopic Hepatectomy Clinical Trial

— LiverLight  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946591
• Other study ID #: 26/21
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
• Contact: Gregor A. Stavrou, MD
• Phone: 0049681963 2441
• Email: gstavrou[@]klinikum-saarbruecken.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Hepatectomy

Locations

Country	Name	City	State
Germany	Klinikum Saarbrücken	Saarbrücken	Saarland

Sponsors (1)

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

Country where clinical trial is conducted

Germany, 

Outcome

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