Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
研究概览
简要总结
" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.
There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.
This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with gastric adenocarcinoma pathologically before surgery
- •Patients aged between 20 to 80
- •Patients with an ECOG 0 or 1
- •Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery
排除标准
- •Patients with abnormal liver function test befor surgery
- •Patients who diagnosed liver cirrhosis or infectious liver disease
- •Patients who underwent liver resection, or chemotherapy for gastric cancer
- •Patients planned for combined liver resection or cholecystectomy during gastrectomy
研究组 & 干预措施
Group1
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
干预措施: Group1 (Procedure)
Group2
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
干预措施: Group2 (Procedure)
Group3
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
干预措施: Group3 (Procedure)
结局指标
主要结局
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
时间窗: Real time near-infrared fluorescence image will be obtained during the surgery.
Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging. The order of the algorithm is as follows: First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed. After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging. The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.
次要结局
- Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)(Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.)
研究者
In Gyu Kwon
Associate Professor
Gangnam Severance Hospital