Liver CancerNCT07295275
Safety and Efficacy of Transarterial ICG Fluorescence-Guided Laparoscopic Anatomical Liver Resection
An observational study of Liver Cancer, run by West China Hospital at 3 sites in China.
Trial summary
This multicenter, ambispective cohort study evaluates the safety and efficacy of trans-arterial Indocyanine Green (ICG) fluorescence-guided laparoscopic liver watershed resection for Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 80 years with a histopathological diagnosis of Hepatocellular Carcinoma (HCC). The population consists of patients who have undergone (retrospective cohort) or are scheduled to undergo (prospective cohort) laparoscopic anatomical liver resection guided by Indocyanine Green (ICG) fluorescence imaging at one of the participating centers. Participants must have Child-Pugh class A or B liver function and no evidence of major vascular invasion or distant metastasis.
Who may be able to join
- Age 18-80 years.
- Postoperative histopathological diagnosis of Hepatocellular Carcinoma (HCC).
- Underwent ICG fluorescence-guided laparoscopic anatomical liver resection.
- Child-Pugh Class A or B.
- ASA score I-III.
- ECOG Performance Status 0-2.
- No invasion of major vessels (main portal vein/first-order branches, main hepatic vein).
- No distant metastasis.
Who cannot join
- Pathology confirms non-HCC components (e.g., cholangiocarcinoma, combined HCC-ICC) or metastatic liver cancer.
- Concomitant other active malignancies.
- Preoperative anti-tumor therapy (TACE, ablation, radiotherapy, systemic therapy) or history of prior hepatectomy.
- Ruptured tumor.
- Conversion to open surgery.
- Unclear surgical records regarding ICG staining method.
- Intraoperative ICG staining failure (e.g., diffuse staining, unclear boundaries) preventing fluorescence-guided resection.
- Missing data preventing primary endpoint assessment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Lei Yang Professor, 18810127955
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Jiwei Huang Professor, 18980606725, huangjiwei@wchscu.cn
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Lin Zhang Professor, 17683009870
About this study
Official title: Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
This multicenter, ambispective cohort study evaluates the safety and efficacy of trans-arterial Indocyanine Green (ICG) fluorescence-guided laparoscopic liver watershed resection for Hepatocellular Carcinoma (HCC). The study aims to compare the outcomes of the trans-arterial ICG staining approach versus the conventional trans-portal (portal vein) ICG staining approach.
Read the detailed description
The study employs an ambispective design, comprising:
A Retrospective Cohort: Collecting clinical data from patients treated between June 2020 and August 2025.
A Prospective Cohort: Enrolling new patients from January 2026 to January 2027. Data will be collected from three medical centers. The primary objective is to compare the oncological prognosis, specifically Recurrence-Free Survival (RFS), between the two navigation methods. Secondary objectives include perioperative safety, liver function recovery, and Overall Survival (OS).
- Conditions
- Liver Cancer
- Being tested
- Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)
- Keywords
- Laparoscopic Anatomical Liver Resection, Indocyanine Green Fluorescence, Hepatocellular Carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)Procedure or surgery
Laparoscopic liver resection using ICG fluorescence imaging for tumor and liver segment visualization. Comparison lies in the route of ICG administration (Arterial vs. Portal).
| Study group | Role | What they receive |
|---|---|---|
| Transarterial ICG Group | Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG. Receives: Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG) | |
| Transportal ICG Group | Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
RFS is defined as the time interval from the date of surgery to the date of first documented tumor recurrence (intrahepatic or extrahepatic) or death from any cause. Evaluated using Kaplan-Meier analysis.
Measured: Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)
Secondary outcomes (2)
Overall Survival (OS)
OS is defined as the time from the date of surgery to the date of death from any cause.
Measured: Up to 3 years post-surgery
Incidence of Perioperative Complications
Number of participants with postoperative complications (e.g., bile leakage, hemorrhage, infection, liver failure), graded according to the Clavien-Dindo classification system.
Measured: From surgery up to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwei Huang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295275
- Sponsor's protocol ID
- JHuang20235
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07295275
- Acronym / sponsor ID
- JHuang20235
- Conditions
- Liver Cancer
- Keywords
- Laparoscopic Anatomical Liver Resection, Indocyanine Green Fluorescence, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Dec 2025 (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.
This multicenter, ambispective cohort study evaluates the safety and efficacy of trans-arterial Indocyanine Green (ICG) fluorescence-guided laparoscopic liver watershed resection for Hepatocellular Carcinoma (HCC). The study aims to compare the outcomes of the trans-arterial ICG staining approach versus the conventional trans-portal (portal vein) ICG staining approach.
Detailed description
The study employs an ambispective design, comprising:
A Retrospective Cohort: Collecting clinical data from patients treated between June 2020 and August 2025.
A Prospective Cohort: Enrolling new patients from January 2026 to January 2027. Data will be collected from three medical centers. The primary objective is to compare the oncological prognosis, specifically Recurrence-Free Survival (RFS), between the two navigation methods. Secondary objectives include perioperative safety, liver function recovery, and Overall Survival (OS).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarterial ICG Group | – | Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG. |
| Transportal ICG Group | – | –Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 80 years with a histopathological diagnosis of Hepatocellular Carcinoma (HCC). The population consists of patients who have undergone (retrospective cohort) or are scheduled to undergo (prospective cohort) laparoscopic anatomical liver resection guided by Indocyanine Green (ICG) fluorescence imaging at one of the participating centers. Participants must have Child-Pugh class A or B liver function and no evidence of major vascular invasion or distant metastasis.
Key inclusion criteria (8 listed)
- Age 18-80 years.
- Postoperative histopathological diagnosis of Hepatocellular Carcinoma (HCC).
- Underwent ICG fluorescence-guided laparoscopic anatomical liver resection.
- Child-Pugh Class A or B.
- ASA score I-III.
Key exclusion criteria (8 listed)
- Pathology confirms non-HCC components (e.g., cholangiocarcinoma, combined HCC-ICC) or metastatic liver cancer.
- Concomitant other active malignancies.
- Preoperative anti-tumor therapy (TACE, ablation, radiotherapy, systemic therapy) or history of prior hepatectomy.
- Ruptured tumor.
- Conversion to open surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)Laparoscopic liver resection using ICG fluorescence imaging for tumor and liver segment visualization. Comparison lies in the route of ICG administration (Arterial vs. Portal). | Procedure or surgery | Transarterial ICG Group |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)
RFS is defined as the time interval from the date of surgery to the date of first documented tumor recurrence (intrahepatic or extrahepatic) or death from any cause. Evaluated using Kaplan-Meier analysis.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years post-surgery
Incidence of Perioperative Complications
Time frame: From surgery up to 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by West China Hospital at 3 sites in China.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Huang Professor (18980606725, huangjiwei@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)). 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 3 Mar 2026.