Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
研究概览
简要总结
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).
The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.
详细描述
Inclusion Criteria:
- Woman aged 18 years or more
- All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- Informed and signed consent
Exclusion Criteria:
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- Allergy to fluorescein
- Previous allergy or anaphylactic shock during an angiography
- Allergic or hypersensibility reactions
- Severe asthma, chronic cardiac or pulmonary diseases
- Restricted renal function
- Patient under a beta-blockers treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Woman aged 18 years or more
- •All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- •Informed and signed consent
排除标准
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •Pregnancy, ongoing or planned during the study period
- •Allergy to fluorescein
- •Previous allergy or anaphylactic shock during an angiography
- •Allergic or hypersensibility reactions
- •Severe asthma, chronic cardiac or pulmonary diseases
- •Restricted renal function
- •Patient under a beta-blockers treatment
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision
研究组 & 干预措施
bilateral laparoscopic salpingectomy
干预措施: bilateral laparoscopic salpingectomy (Procedure)
bilateral laparoscopic salpingectomy
干预措施: endomicroscopy Cellvizio® system (Device)
结局指标
主要结局
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
时间窗: DAY 1
次要结局
- : Description of the optical biopsy pictures in order to state a classification(DAY 1)