跳至主要内容
临床试验/NCT02547909
NCT02547909撤回不适用

The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis

Dr. Ofir Harnoy MD1 个研究点 分布在 1 个国家开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
recognizing unique pCLE images for endometriosis

研究概览

简要总结

Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.

详细描述

Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus, most commonly over the ovaries, fallopian tubes, bladder, recto-sigmoid colon and the uterine myometrium.Endometriosis affects 5%-15% of women in the reproductive age causing pelvic or abdominal pain, infertility and occasionally rectal bleeding (if involving the bowel). Deep endometriosis is mostly defined as a single endometrial nodule, usually larger than 1 cm which is located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Those lesions usually infiltrate at least 5 mm into the tissue involved. The gold standard of diagnosis is histological proven endometriosis, usually obtained during explorative laparoscopy. Other imaging tests that aid in the diagnosis are trans-vaginal or trans-rectal sonography (TRUS), MRI & CT. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Negative (normal) laparoscopy is highly accurate in excluding endometriosis, but a positive laparoscopy (i.e. with macroscopic findings) without biopsy has a limited value. In practice, many clinicians refrain from taking biopsies due-to the risk of bowel surgery, particularly on an un-prepared bowel. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel 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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Endometriosis

排除标准

  • Unable or unwilling to give and sign an informed consent
  • Allergy to fluorescein
  • Critical illness
  • Pregnancy
  • Malignancy

研究组 & 干预措施

Study group

Experimental

a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.

干预措施: probe-based Confocal Laser Endomicroscopy (Procedure)

Study group

Experimental

a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.

干预措施: Cellvizio (Device)

Study group

Experimental

a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.

干预措施: fluorescein 10% (Drug)

结局指标

主要结局

recognizing unique pCLE images for endometriosis

时间窗: intraoperative

次要结局

未报告次要终点

研究者

发起方
Dr. Ofir Harnoy MD
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr. Ofir Harnoy MD

Staff physician

Sheba Medical Center

研究点 (1)

Loading locations...

相似试验