Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
研究概览
简要总结
This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.
详细描述
Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.
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
- •Informed Consent as documented by signature
- •Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
- •Patients should be in follicular phase
- •Have chronic pelvic pain and/or Infertility and be willing to undergo planned endometriosis resection procedure.
排除标准
- •Known or suspected allergy to iodine, shellfish, or ICG dye
- •Hyperthyroidism
- •Severe renal insufficiency
- •Simultaneous therapy with beta-blockers
- •Women who are pregnant (positive HCG in the blood) or breast feeding
- •Intention to become pregnant during the course of the study
- •Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia)
- •Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated markers of infection in the blood)
- •Previous history of radiation therapy of the pelvis
- •Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery
研究组 & 干预措施
Interventional Arm, ICG and NIR imaging
NIR fluorescence imaging is performed after white light laparoscopy. 0.3mg/kg bodyweight of ICG is administered i.v. All suspected lesions are removed and labeled whether they are seen in WL or NIR imaging or both. Evaluation is performed after the histological analysis of the lesions.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
时间窗: The duration of the participation is from the signature of the informed consent until the end of the hospitalisation, expected to be on average after 2 to 4 days
The number of histologically proven endometriotic lesions detected with NIR fluorescence imaging are compared to the number of lesions detected with white light laparoscopy alone and white light laparoscopy plus NIR fluorescence imaging.
次要结局
未报告次要终点