Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Detection of endometriotic lesions
研究概览
简要总结
The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation
详细描述
Patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria.
The first abdominal and pelvi's inspection was made using direct laparoscope visualization under white light conditions. All areas suspected of peritoneal endometriosis were classified as white, black and red lesions and recorded together with their anatomic location in the surgical record for the purposes of subsequent extirpation.
After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW) Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green imaging mode were recorded with their corresponding appearance in white light mode.
If suspected areas were visible either in white light or Indocyanine Green imaging mode, specific sample has been taken from these areas.
In addition control biopsy specimens from inconspicuous peritoneum has been taken.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suspected endometriosis with necessity for laparoscopic confirmation and resection
- •Regular menstrual cycles
排除标准
- •Patients younger than 18 years and older than 50 years at time of operation
- •Subject with previous history of adverse reaction or allergy to Indocyanine Green, iodine, shellfish or iodine dyes
- •Documented allergy to sulfur containing compounds
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Indocyanine Green
- •Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (Total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal)
- •Subject has uremia, serum creatinine (> 2.0 mg/dl)
- •Subject has severe coronary heart disease (instable angina pectoris)
- •Pregnant or breast-feeding women
- •Subject actively participating in another drug, biologic and/or device protocol
- •The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
- •Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
研究组 & 干预措施
Indocyanine Green arm
All the enrolled patients met the inclusion criteria. No patients have been excluded from the study. All patient have been subjected, during laparoscopy, to an accurate inspection of the abdomen and all the visible endometriotic lesions have been described. Subsequently, 0.25 mg /(kg BW) Indocyanine Green were administered intravenously during surgery and a second look of the abdomen and pelvis with the Near Infrared Vision has been made, in order to identify the fluorescent lesions. All the lesions has been described and localized pre and post the Indocyanine Green injection and then removed and properly cataloged
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Detection of endometriotic lesions
时间窗: Intraoperative
Optical qualitative assessment through the visual evaluation of a single expert surgeon (presence / absence of fluorescence, due to the injection of the Indocyanine Green and the use of the Near Infrared vision, at the level the of suspected endometriotic lesions)
次要结局
- Localization of occult endometriotic lesion(Intraoperative)
- Operatory Time(Intraoperative)
- Complications(From operatory room up to 3 days)
- Side effects(From operatory room up to 3 days)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart