Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.
研究概览
简要总结
This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.
详细描述
This study is being done to find out if an endoscope (a small, flexible tube with a camera mounted on the end) passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic route is as fast and efficient as the laparoscopic route, which is the current standard of care.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-80
- •Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma
排除标准
- •Inability to obtain informed consent
- •Pregnancy
- •Intra-abdominal adhesions that preclude endoscopy
- •Contraindication to upper endoscopy such as stricture, stenosis of the foregut
- •Previous gastric surgery
- •Diagnosis of pancreatic body or tail tumor
- •History or current diagnosis of gastric ulcer
- •Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging
- •Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging
- •Antiplatelet medication not stopped at least 7 days prior to procedure
- •Anticoagulant medication not stopped at least 5 days prior to procedure
结局指标
主要结局
Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.
时间窗: Intraoperatively
次要结局
- Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration.(1 year)
- Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.(Intraoperatively)
研究者
Jeffrey Hazey
Associate Professor
Ohio State University