Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Liver resection navigation success rate
研究概览
简要总结
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).
详细描述
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.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Experimental group
Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.
干预措施: Laparoscopic surgical navigation system (Device)
Experimental group
Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Liver resection navigation success rate
时间窗: intraoperative
Whether this technique successfully displayed the pre-resection line during the surgery were recorded.
次要结局
- Postoperative complication rate(3 months)
- Operative outcomes(intraoperative)