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临床试验/NCT01944930
NCT01944930已完成1 期

Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Lahey Clinic2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年1月最近更新:
适应症

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

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

发起方
Lahey Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Desmond H. Birkett

Chair, Department of General Surgery, Lahey Medical Center

Lahey Clinic

研究点 (2)

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