Diagnostic Yield of Narrow Band Imaging (NBI) and Standard Visible White Light Laparoscopy for the Detection of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 4
- 主要终点
- Diagnostic Yield
研究概览
简要总结
Endometriosis is a relatively common chronic gynecological condition that affects approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that is characterized by the presence of endometrial glands and stroma outside of the uterine cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility; the severity of pain associated with this disease often leads to a considerable decrease in quality of life.
The standard treatment for severe pelvic pain and infertility is to surgically remove endometriotic areas. Identifying all endometriotic lesions is paramount to "optimal endometriosis debulking." The inability to see all endometriosis lesions has been thought to be a factor for patients with little or no relief following surgery. Using the Narrow Band Imaging (NBI) method has the potential to improve visualization of endometriosis lesions, assist in debulking and thus, result in improved clinical outcomes.
NBI is a technique that uses a specific narrow wavelength of light to change the normal color contrasts of the endoscopic image and improve detection of neovascularization, which is the pathological feature of endometriosis for both superficial and deeper vascularization. This type of imaging has the potential to offer improved discrimination of lesions, increasing diagnostic yield as well as resulting in more complete debulking.
This study is designed to determine the degree to which NBI improves the detection and diagnosis of endometriosis lesions. Data collected during the study will be used to test the hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic lesions at the time of laparoscopy compared to standard visible white light examination. Furthermore, this study will also determine the impact of the use of NBI compared to use of white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months following surgery.
Hypotheses:
The use of NBI in addition to white light examination will improve the diagnostic yield of endometriotic lesions at the time of laparoscopy compared to only using white light examination.
The use of NBI in addition to white light examination will improve the sensitivity of detecting endometriotic lesions and reduce false positives at laparoscopy compared to only using white light examination.
Secondarily, the use of NBI will be associated with a greater reduction in pain at the 6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone because of improved lesion identification and debulking.
详细描述
Introduction:
Endometriosis is a relatively common chronic gynecological condition that affects approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that is characterized by the presence of endometrial glands and stroma outside of the uterine cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility; the severity of pain associated with this disease often leads to a considerable decrease in quality of life.
The standard treatment for severe pelvic pain and infertility is to surgically remove endometriotic areas. Identifying all endometriotic lesions is paramount to "optimal endometriosis debulking." The inability to see all endometriosis lesions has been thought to be a factor for patients with little or no relief following surgery. Using the Narrow Band Imaging (NBI) method has the potential to improve visualization of endometriosis lesions, assist in debulking and thus, result in improved clinical outcomes.
NBI is a technique that uses a specific narrow wavelength of light to change the normal color contrasts of the endoscopic image and improve detection of neovascularization, which is the pathological feature of endometriosis for both superficial and deeper vascularization. This type of imaging has the potential to offer improved discrimination of lesions, increasing diagnostic yield as well as resulting in more complete debulking.
The results of a pilot study of 21 patients conducted at Mercy Medical Center demonstrated that use of NBI resulted in the diagnosis of pathologically-proven endometriosis among 4 patients whose lesions were missed with visible white light only examination. In addition, the number of confirmed endometriosis lesions increased with the use of NBI in addition to white light. The study also suggested that NBI may assist in discriminating endometriosis from other lesions, thus reducing false positives: one patient had no lesions detected with NBI and the lesions biopsied based on visible white light examination were not endometriosis at pathologic examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older
- •Women of reproductive age (less than 50 years) undergoing diagnostic laparoscopy for suspected endometriosis.
- •Willingness to provide informed consent
排除标准
- •Pregnancy
- •General health issues that the physician determines would make laparoscopy unsafe.
结局指标
主要结局
Diagnostic Yield
时间窗: Day of surgery, day 1
Diagnostic yield in this study is defined as the number of patients undergoing the surgical procedure who are diagnosed, based on pathology, with endometriosis. It is hypothesized that the diagnostic yield will be statistically and significantly higher among patients randomized to white light/NBI compared to those randomized to white light/white light.
Sensitivity
时间窗: Day of surgery, day 1
Sensitivity in this study is defined as the number of lesions biopsied that are determined, based on pathology, to be endometriotic divided by the number of total lesions biopsied. It is hypothesized that the sensitivity for detecting endometriotic lesions will be higher in the white light/NBI arm compared to the white light/white light arm.
次要结局
- Self-reported Pain(6 weeks, 3 months and 6 months [post surgery])
研究者
Fermin Barrueto
Physician
Mercy Medical Center