A trial of the imaging and surgical quality of indocyanine green staining method in laparoscopic liver resection

Comparison of the imaging and surgical quality between positive and negative staining in indocyanine green fluorescence-guided laparoscopic liver resection: a randomized controlled trial - RCT for comparing ICG positive and negative staining in fluorescence-guided liver resection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049815

Enrollment

Registered

2023-01-01

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma, metastatic liver cancer, intrahepatic cholangiocarcinoma, benign liver tumor

Interventions

Negative staining group: At the early phase during the surgery, extrahepatic (extrafascial) Glissonean approach is performed to encircle the target Glissonean pedicle feeding the tumorous area exactl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: male or female patients with primary or metastatic liver tumors, 20 years or older, scheduled for elective LLR, preserved liver function, able to understand the nature of the study, and willing to join and give voluntary written consent. Liver functional reserve will be evaluated by serum biochemical tests (albumin level, total bilirubin level and prothrombin time) and ICG retention rate at 15 minutes (ICG-15R). The severity of liver function is assessed based on Child-Pugh stages and the liver damage classification defined by the Liver Cancer Study Group of Japan.15 Preserved liver function is defined as an ICG-15R less than 15% and a Child-Pugh classification A or B.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: repeat liver resection, tumor in segment 1, severe liver or renal insufficiency, ICG hypersensitivity, pregnant or breastfeeding, or unable to understand the nature of the study or refuse it.

Design outcomes

Primary

Measure	Time frame
To determine the ability of the guidance in anatomic resection, the primary endpoint is the success rate of the ICG staining which consists of a subjective optical scoring based on three components: superficial demarcation in the liver surface, visualization of parenchymal borders, and consistency with the preoperative three-dimensional (3D) simulation. The resection margin and the shape/weight of the specimen in comparison with the pre- and post-operative 3D simulations of the liver will be evaluated as well.	—

Measure

Time frame

To determine the ability of the guidance in anatomic resection, the primary endpoint is the success rate of the ICG staining which consists of a subjective optical scoring based on three components: superficial demarcation in the liver surface, visualization of parenchymal borders, and consistency with the preoperative three-dimensional (3D) simulation. The resection margin and the shape/weight of the specimen in comparison with the pre- and post-operative 3D simulations of the liver will be evaluated as well.

—

Secondary

Measure	Time frame
Short-term surgical outcomes and recurrence-free survival at 1-year	—

Countries

Japan

Contacts

Public ContactTaiga Wakabayashi

Ageo Central General Hospital Center for Advanced Treatment of Hepatobiliary and Pancreatic Diseases

taiga.wakabayashi@me.com0487731111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026