Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 7
- 主要终点
- Lymph nodes identified compared to imaging
研究概览
简要总结
The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma. The main questions it aims to answer is:
- The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition
- Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumed resectable pCCA OR
- •Presumed resectable iCCA OR
- •Presumed resectable mid-common bile duct CCA OR
- •Presumed unresectable pCCA worked-up for Liver Transplantation AND
- •Written informed consent must be given according to International Council on Harmonisation/Good Clinical Practice guidelines, and national/local regulations AND
- •Age > 18 years.
排除标准
- •Patients with a history of treated CCA
- •Patients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging
- •Patients with a history of treated liver malignancy
- •Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice
结局指标
主要结局
Lymph nodes identified compared to imaging
时间窗: Through study completion, max 1 year
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging
Lymph nodes identified compared to surgery
时间窗: Through study completion, max 1 year
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to surgery, in the patients in which this is performed
次要结局
- Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA(Through study completion, max 1 year)
- Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes(Through study completion, max 1 year)
- Different locations of positive lymph nodes and its effect on survival(Through study completion, max 1 year)
研究者
Dr. L.M.J.W. (Lydi) van Driel
Gastroenterologist, MD, PhD
Erasmus Medical Center