Laparoscopic HepatectomyLiverLightNCT04946591
Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection
An observational study of Laparoscopic Hepatectomy, run by Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Hepatectomy
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with any type of liver tumor undergoing 4K laparoscopic hepatectomy using indocyanine green
Who may be able to join
- Patient consent
- Aged above 18 years
- Undergoing any type of liver resections
Who cannot join
- Unresectable liver tumors
- Known indocyanine green allergy
- Iodine allergy
- Advanced cirrhosis (Child C)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Laparoscopic Hepatectomy
- Keywords
- Indocyanine green, Tumor localization, Bile Leak, Ultra-high-definition
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor localization
Measured: One day
Secondary outcomes (8)
Remnant liver venous drainage
Measured: One day
Detection of resection plane
Measured: One day
Rate of intraoperative bile leak
Using indocyanine green and fluorescence camera
Measured: One day
Rate of postoperative bile leak
Based on the ISGLS criteria
Measured: Three months
Resection margin
Using fluorescence camera
Measured: One day
Rate of morbidity
Based on the Clavien-Dindo classification
Measured: Three months
Duration of hospital stay
Measured: Three months
Rate of mortality
All cause death events
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Aug 2021
- Primary completion1 Jul 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.med Dr. habil Gregor A. Stavrou, Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946591
- Sponsor's protocol ID
- 26/21
- Acronym
- LiverLight
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection: A Single-centre Prospective Study
- ClinicalTrials.gov ID
- NCT04946591
- Acronym / sponsor ID
- LiverLight / 26/21
- Conditions
- Laparoscopic Hepatectomy
- Keywords
- Indocyanine green, Tumor localization, Bile Leak, Ultra-high-definition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische OnkologieUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with any type of liver tumor undergoing 4K laparoscopic hepatectomy using indocyanine green
Key inclusion criteria (3 listed)
- Patient consent
- Aged above 18 years
- Undergoing any type of liver resections
Key exclusion criteria (4 listed)
- Unresectable liver tumors
- Known indocyanine green allergy
- Iodine allergy
- Advanced cirrhosis (Child C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor localization
Time frame: One day
8 secondary outcomes
Remnant liver venous drainage
Time frame: One day
Detection of resection plane
Time frame: One day
Rate of intraoperative bile leak
Time frame: One day
Rate of postoperative bile leak
Time frame: Three months
Resection margin
Time frame: One day
Rate of morbidity
Time frame: Three months
Duration of hospital stay
Time frame: Three months
Rate of mortality
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Hepatectomy, run by Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor localization (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.