Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
研究概览
简要总结
The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier for a surgeon to see cancer.
NBI is a kind of light. Normally, white light is used during surgery. White light uses many wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors.
In this study the surgeon will look with both normal white light and NBI. This way a comparison can be made to determine which is superior.
Improved identification of tumors allows doctors and patients to make informed decisions about whether treatment is needed after surgery. It also provides additional information to determine which treatments may be best.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet one (or more) of the following criteria:
- •Preoperative diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma (all stage, grade and histology)
- •Preoperative diagnosis of grade III endometrial carcinoma (all stage, all histology)
- •Preoperative diagnosis of uterine serous carcinoma (all stage, all grade)
- •Preoperative diagnosis of clear cell endometrial carcinoma (all stage, all grade)
- •Preoperative diagnosis of endometrial carcinosarcoma (all stage, all grade)
- •Gastrointestinal carcinoma (all histology, stage and grade)
- •Pancreatic carcinoma (all histology, stage and grade)
- •Lung cancer (all histology, stage and grade)
- •Esophageal carcinoma (all histology, stage and grade)
- •Suspected or pathologically confirmed metastatic disease to the lung (all disease primaries)
- •Suspected or pathologically confirmed malignant pleural effusion (all disease primaries)
- •Patients must meet all of the following criteria:
- •Planned thorascopic robotic or laparoscopic surgical approach
- •>18 years old
- •Not pregnant
- •Able to give consent Participation in other research protocols does not exclude a patient from participation in this study.
排除标准
- 未提供
研究组 & 干预措施
pts having a thorascopic, laparoscopic or robotic procedure
The procedure will begin with washings (peritoneal) and two assessments of the extent of peritoneal disease. First, a four quadrant inspection of the peritoneal cavity under white light, this is the standard of care assessment. Then, a repeat four quadrant inspection of the peritoneal cavity under NBI will be done, this is the only experimental component of the design. White light imaging will always be done first, followed by NBI. For those patients scheduled for thorascopic procedures: The procedure will begin with sampling of pleural effusions when clinically indicated. Then there will be two assessments of the pleural surfaces. First, an inspection of the pleural cavity under white light, this is the standard of care assessment. Then, a repeat inspection under NBI, this is the only experimental component of the design. White light imaging will always be done first, followed by NBI.
干预措施: Narrow Band Imaging (NBI) (Other)
结局指标
主要结局
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
时间窗: 1 year
次要结局
- Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.(1 year)