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

NCT04946591 | Completed DMC

• 1 other identifier: 26/21
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Hepatectomy

Keywords

Indocyanine green; Tumor localization; Bile Leak; Ultra-high-definition

Outcome Measures

Primary Outcomes (1)

• Tumor localization

  One day

Secondary Outcomes (8)

• Remnant liver venous drainage

  One day

• Detection of resection plane

  One day

• Rate of intraoperative bile leak

  One day

• Rate of postoperative bile leak

  Three months

• Resection margin

  One day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, resected liver specimen

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 1, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

DE (1)