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Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging

Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03811704
Enrollment
50
Registered
2019-01-22
Start date
2016-01-01
Completion date
2021-12-30
Last updated
2019-01-22

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

Conditions

Liver Resection

Keywords

three-dimensional reconstruction, fluorescence, indocyanine green, liver resection, navigation surgery

Brief summary

The aim of this study was to evaluate the feasibility and efficacy of a novel real-time navigation way for laparoscope liver resection, which was fused images comprising 3D imaging and indocyanine green Fluorescence imaging (fusion IGFI).

Detailed description

During liver resection, surgeons cannot completely view the intraparenchymal structure. Although a fluorescent imaging technique using indocyanine green has recently been developed for hepatobiliary surgery, limitations in its application for real-time navigation persist. A nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine green Fluorescence imaging to guide the surgery real-time.

Interventions

DEVICELaparoscopic surgical navigation system

We will use this navigation system to guide de liver resection.

DRUGIndocyanine Green

ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. 18 years≤ Age ≤70 years 2. Compling with the diagnosis criteria of complex hepatic carcinoma. 3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled 4. Preoperative liver function is Child - Pugh grade A or B. 5. The patients are volunteered for the study.

Exclusion criteria

1. Patients with mental illness. 2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.) 3. The patients refused to take part in the study. 4. There are other co-existed malignant tumors. 5. Benign liver diseases. 6. Indocyanine green allergy

Design outcomes

Primary

MeasureTime frameDescription
Liver resection navigation success rateintraoperativeWhether this technique successfully displayed the pre-resection line during the surgery were recorded.

Secondary

MeasureTime frameDescription
Postoperative complication rate3 monthsThe Postoperative complications were recorded.
Operative outcomesintraoperativeOperative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.

Countries

China

Contacts

Primary ContactFang Chihua, M.D.;Ph.D
fangch_dr@126.com+8613609700805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026