Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Fluorescent hepatic segment demarcation area
研究概览
简要总结
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) .
详细描述
Materials and Methods
- 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
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single Hepatocellular carcinoma.
- •plan of Laparoscopic hepatectomy.
- •Age between 20 to 85 y/o.
排除标准
- •allergies to iodine or ICG
- •Liver cirrhosis
- •coagulopathy
- •chronic kidney disease
- •pregnancy
结局指标
主要结局
Fluorescent hepatic segment demarcation area
时间窗: intra-operative period
The surface size of fluorescent enhanced hepatic segment were measured as cm x cm .
the rate of fluorescent demarcation corresponding to US guide resection area
时间窗: intra-operative period
The evaluation of the fluorescent hepatic surface which is included in the resected area or not
The minimal distance between tumor and fluorescent margin
时间窗: intra-operative period
The distance between tumor edge and fluorescent parenchyma edge was measured as cm. This purpose was to evaluation the oncologic safety if the resection line is following the fluorescent margin
surgical benefit rate of fluorescent image
时间窗: intra-operative period
If the fluorescent enhanced area is similar to resected parenchyma or the information of fluorescent image change the primary surgical plan, it was indicated benefit for surgery.
The minimal surgical margin
时间窗: intra-operative period
The distance between tumor edge and resected parenchyma edge was measured as cm.
次要结局
- Post operative angiography procedure complication(one months after operation)
- Post operative complication(one months after operation)
- Post operative hospital stay(one months after operation)
- Post operative Mortality(any complication related to surgery)