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Arterial Base Fluorescence Segmental Positive Staining

NCT04266548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-12

No results posted yet for this study

Summary

More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Intraoperative liver segmentation can be obtained by ultrasound-guide intraportal injection of a fluorophore and illuminating with a Near-Infrared light source for positive staining and by intravenous injection after ligation of segmental vessels for negative staining .The ultrasound guide intraportal injection approach is challenging in the minimally-invasive setting. However hepatocelluar carcinoma(HCC) was supplied by hepatic artery mainly. The investigators aimed to evaluate the feasibility of arterial base positive staining for fluorescence liver segmentation in human by superselective intra-hepatic artery injection of Indocyanine Green (ICG) .

Conditions

  • Hepatic Carcinoma

Interventions

PROCEDURE

Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining

The patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yu-Yin Liu, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2019-12-06
Completion
2020-01-06

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266548 on ClinicalTrials.gov