The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of detected endometriotic lesions with Near Infrared Light versus with white light
研究概览
简要总结
Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected
- •Able to understand the nature of the study and what will be required of them
- •Age >18years
- •Premenopausal
- •No history of impaired liver and renal function
- •No history of hypersensitivity or allergy to indocyanine green or iodide
- •No hyper-thyroidism or autonomic thyroid adenomas
- •Willing to participate
排除标准
- •Not able to give written informed consent
- •Aged < 18 years
- •Pregnant or breast-feeding women
- •Known hypersensitivity or allergy to indocyanine green or iodide
- •Known hyper-thyroidism or autonomic thyroid adenomas
- •Not willing to participate
研究组 & 干预措施
NIRF imaging
After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics
干预措施: NIRF imaging (Device)
结局指标
主要结局
Number of detected endometriotic lesions with Near Infrared Light versus with white light
时间窗: during surgery
The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light.
次要结局
- Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye(during surgery)
- Histological assessment of taken biopsies: assessment of localization of ICG uptake(biopsies taken during surgery, which are assessed during the 1th week after surgery)
- Time measurement(during the laparoscopic procedure)
- Satisfaction of the surgeon with the technique(immediately after surgery)
- Histological assessment of taken biopsies: assessment Target to background ratio(biopsies taken during surgery, which are assessed during the 1th week after surgery)