Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Detection rate of a second cancer or precancerous lesions
研究概览
简要总结
This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.
详细描述
Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.
This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.
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
- Single (Participant)
盲法说明
The participants don't know which arm they were allocated to.
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
- •All participants with the need of PEG due to head neck cancers or esophageal carcinoma
排除标准
- •Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG
结局指标
主要结局
Detection rate of a second cancer or precancerous lesions
时间窗: The time frame is during the PEG insertion (approximately 15min)
The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy
次要结局
未报告次要终点
研究者
Georg Dultz
Record Keeper
Johann Wolfgang Goethe University Hospital