Biliary Tissue Sampling Using a Cytology Brush or the G.I.U.M. Catheter: a Prospective Randomized Controlled Study.
试验速览
- 阶段
- 1 期
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Sensitivity and specificity for the diagnosis of malignancy with both devices
研究概览
简要总结
Introduction In patients with a biliary obstruction, tissue is acquired immediately before drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by passing a brush inside the bile duct stricture. However, brush cytology has a modest sensitivity (30-57%) for the diagnosis of cancer. A device, called the "G.I.U.M." catheter, allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology. The aim of this study is to compare the diagnostic yield of tissue sampling performed in patients with a suspected malignant biliary stricture using 2 techniques, namely a standard brush catheter and the G.I.U.M..
Protocol design Eligible patients will have tissue sampling performed using both techniques during ERCP, the first technique used being randomly assigned and immediately followed by the other one as well as biliary decompression. All specimens obtained will be subjected to cytopathological examination. After inclusion of the total number of patients, smears will be anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical diagnosis in each case will be based on cytologic results plus histological examination of biopsy specimens.
详细描述
Introduction
Many patients with a suspected malignant biliary obstruction are considered unsuitable for surgery because of locally advanced or metastatic disease or poor clinical performance status. Management of these patients is facilitated by a tissue diagnosis at initial endoscopic retrograde cholangio-pancreatography (ERCP). This may obviate further invasive tests, and the most suitable nonsurgical treatment can be initiated without delay. Brush cytology is the most frequently used technique. The procedure is relatively easy to perform, requires little time, and generally is safe. Although its specificity is close to 100%, brush cytology has a modest sensitivity that ranges from 30% to 57% in most published studies .
A device, called the "G.I.U.M." catheter has been developed to increase the amount of tissue available for analysis 1. It consists of a basket with multiple wires that can be passed through the stricture, and grasp tissue between the wires. It has been shown in an uncontrolled study to allow for the diagnosis of malignancy with a high sensitivity (Endoscopy, submitted for publication).
The aim of this study is to compare the diagnostic yield of tissue sampling performed using a standard brush catheter and the G.I.U.M. in patients with a suspected malignant biliary stricture.
Selection of patients
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
- Double
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
- •Suspicion of malignant biliary stricture without prior histopathologic confirmation;
- •Informed consent for ERCP, including sampling and dilation modalities, obtained.
排除标准
- •Coagulopathy not corrected by administration of vitamin K or fresh frozen plasma;
- •Inability to pass a guidewire through the stricture;
- •Hilar stricture
结局指标
主要结局
Sensitivity and specificity for the diagnosis of malignancy with both devices
次要结局
- 30-day complication rate.
- unusual findings at histopathological examination of surgical specimens.