Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Rate of Detectable Peritoneal Metastases
研究概览
简要总结
Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
排除标准
- •clinical contraindication to diagnostic laparoscopy
结局指标
主要结局
Rate of Detectable Peritoneal Metastases
时间窗: After each Laparoscopy, at time of procedure
number of additionally visualized peritoneal lesions
次要结局
未报告次要终点
研究者
Desmond H. Birkett
Chair, Department of General Surgery, Lahey Medical Center
Lahey Clinic
