A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Probability of diagnosis of metastasis (frequency)
研究概览
简要总结
The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.
详细描述
To evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer. All analyses are performed using SAS version 9.1.3 for Windows (SAS institute, Cary, NC). Clinical and pathological variables will be analyzed using the χ2 test (or Fisher's exact test) and the Student's t test, depending on the normality of the distribution. P-values of < 0.05 are considering statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT)
- •No evidence of distant metastasis
- •aged 15-80 year old
- •performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •adequate organ functions defined as indicated below
- •WBC 3000 ~ 12 000/mm3
- •> Hb 8.0 g/dl
- •> Plt 100 000/mm3
- •< Cr 1.2 mg/dl
- •> Ccr 60 ml/min/body
排除标准
- •cystic neoplasm, neuroendocrine tumors
- •pregnant or breast-feeding women
- •previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition
- •unstable angina or myocardial infarction within 6 months of the trial
- •unstable hypertension
- •congestive heart failure
- •severe respiratory disease requiring continuous oxygen therapy
- •liver failure
- •systemic administration of corticosteroids
- •severe mental disorder
研究组 & 干预措施
Staging laparoscopy
Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) and no evidence of distant metastasis.
Staging laparoscopy will perform through 2 ports and a 30˚ laparoscope is inserted into the peritoneal cavity. Examining the whole abdominal wall, including the parietal and visceral peritonea, we will observe the liver surface from the dome area to the inferior surface and hepatoduodenal ligament in order to find metastatic nodules. Laparoscopic ultrasound (US) will be used to overcome in inspecting the posterior part of the liver. After complete laparoscopic examination, peritoneal lavage will be performed through the laparoscopic port.
干预措施: Staging Laparoscopy (Procedure)
Staging laparoscopy
Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) and no evidence of distant metastasis.
Staging laparoscopy will perform through 2 ports and a 30˚ laparoscope is inserted into the peritoneal cavity. Examining the whole abdominal wall, including the parietal and visceral peritonea, we will observe the liver surface from the dome area to the inferior surface and hepatoduodenal ligament in order to find metastatic nodules. Laparoscopic ultrasound (US) will be used to overcome in inspecting the posterior part of the liver. After complete laparoscopic examination, peritoneal lavage will be performed through the laparoscopic port.
干预措施: Laparoscopic ultrasound (Device)
结局指标
主要结局
Probability of diagnosis of metastasis (frequency)
时间窗: baseline
Probability of diagnosis of metastasis (frequency)
次要结局
未报告次要终点
研究者
Sang-Jae Park
Center for Liver Cancer
National Cancer Center, Korea