Clinical trial NCT04266548: Arterial Base Fluorescence Segmental Positive Staining
Official title: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Carcinoma
Keywords: indocynide green
Image guide surgery
near infra-red laparoscopy
laparoscopic hepatectomy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Single Hepatocellular carcinoma.
* plan of Laparoscopic hepatectomy.
* Age between 20 to 85 y/o.

Exclusion Criteria:

* allergies to iodine or ICG
* Liver cirrhosis
* coagulopathy
* chronic kidney disease
* pregnancy

Primary outcomes:
measure: Fluorescent hepatic segment demarcation area
timeFrame: intra-operative period
measure: the rate of fluorescent demarcation corresponding to US guide resection area
timeFrame: intra-operative period
measure: The minimal distance between tumor and fluorescent margin
timeFrame: intra-operative period
measure: The minimal surgical margin
timeFrame: intra-operative period
measure: surgical benefit rate of fluorescent image
timeFrame: intra-operative period
Secondary outcomes:
measure: Post operative complication
timeFrame: one months after operation
measure: Post operative angiography procedure complication
timeFrame: one months after operation
measure: Post operative hospital stay
timeFrame: one months after operation
measure: Post operative Mortality
timeFrame: any complication related to surgery
Other outcomes:
Locations:
city: Niaosong
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Kaohsiung
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Yin Liu, MD
role: STUDY_DIRECTOR
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