Arterial Base Fluorescence Segmental Positive Staining
Condition: Hepatic Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

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) .
    

Detailed description: 
      Materials and Methods

        1. Participants The present prospective, single-center, feasibility study of fluorescence
           demarcation of hepatic segment including HCC by means of direct super-selective
           intrahepatic artery ICG injection. Patients were enrolled according to the following
           criteria: single HCC, scheduled for laparoscopic hepatectomy for curative resection, age
           ranging from 20 to 85 years old, absence of proven or suspected allergies to iodine or
           ICG, absence of coagulopathy, absence of diseases contraindicating general anesthesia,
           and absence of pregnancy.

           All the bio-chemical test, cardiac echo , cardiac thalium test, ICG clearance test,
           Liver CT or MRI were obtained before operation

        2. Equipment Endovascular procedure was performed in the conventional angiography room and
           laparoscopic hepatecotmy was done in operating room at the Kaohsiung Chang Gung memorial
           hospital. Near infra-red fluorescence laparoscopy was used to acquire the fluorescence
           signal arising from the liver parenchyma after Indocyanine Green (ICG) injection.

        3. Procedures

             1. Celiac trunk angiography and super-selective hepatic angiography:

                A 4 Fr angiography sheath (Terumo Europe NV, Belgium) was placed under aseptic
                conditions in the right femoral artery, using the Seldinger technique. A 4 Fr
                Cobra-2 catheter (Terumo Europe NV, Belgium) was positioned at the origin of the
                celiac trunk. A selective celiac trunk digital subtraction angiographic (DSA) run
                was performed, after injection of a contrast medium (Visipaque 270, GE Healthcare;
                Buckinghamshire, United Kingdom), 28mL at a rate of 4mL/sec. A 2.7 French
                micro-catheter (Progreat™, Terumo Europe NV; Belgium) was used to super-selectively
                catheterize different hepatic segmental arteries supplying the target hepatic
                segment including HCC. In all cases, the position was controlled by performing DSA
                and angio computer tomography runs with selective micro-catheter injections. The
                micro-catheter was then perfused with saline and left in place until surgery. Then
                the patients were transferred to operative room while operative room available.

             2. Evaluation of hepatic segmental demarcation using NIR real-time imaging during
                laparoscopic hepatectomy:

      The patients underwent a standard 5-port laparoscopic hepatectomy, which was performed by 2
      experienced laparoscopic surgeons .

      Stage I : the liver mobilization was performed for preparing the hepatectomy. The
      intraoperative ultrasound was used for localization of HCC. The resection line was defined as
      principle of laparoscopic hepatectomy such as surgical margin, surgical volume and etc. The
      pringle control device was prepared.

      Stage II : Rea-time enhanced visualization of the hepatic segment which were supplied feeding
      artery was achieved by means of fluorescence imaging using a direct selective intrahepatic
      artery injection of a 5 mL bolus of ICG (DiagnoGreen®, Taiwan, ROC) at a concentration of
      0.125mg/mL. The demarcation of enhanced hepatic segment were defined. The correspondence
      between the fluorescence margin and ultrasound(US) guide resection line were analized.

      Stage III: The surgical resection line was chose by real time clinical judgement including
      analysis of information of US, artery-base CT, fluorescence image, liver anatomy and patient
      condition. The laparoscopic hepatectomy was performed with pringle vascular control.

      Stage IV: the specimen information including tumor size and margin in vitro was recoded. The
      distance between surgical margin and enhanced liver were measured.
    

Intervention name(s): Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: The study was the clinical feasibility study. Only selected single HCC patients was enrolled to study the feasibility of image guide surgery for laparoscopic hepatectomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: indocynide green; Image guide surgery; near infra-red laparoscopy; laparoscopic hepatectomy