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

Study Overview
=================
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.

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

Conditions
-----------------
Liver Resection

Intervention / Treatment
-----------------
* Device: Laparoscopic surgical navigation system
* Drug: Indocyanine Green


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years≤ Age ≤70 years Compling with the diagnosis criteria of complex hepatic carcinoma. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled Preoperative liver function is Child - Pugh grade A or B. The patients are volunteered for the study. Exclusion Criteria: Patients with mental illness. 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.) The patients refused to take part in the study. There are other co-existed malignant tumors. Benign liver diseases. Indocyanine green allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance. | Device: Laparoscopic surgical navigation system<br>* We will use this navigation system to guide de liver resection.<br>Drug: Indocyanine Green<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver resection navigation success rate | Whether this technique successfully displayed the pre-resection line during the surgery were recorded. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | The Postoperative complications were recorded. | 3 months | 
| Operative outcomes | Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded. | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
three-dimensional reconstruction, fluorescence, indocyanine green, liver resection, navigation surgery