A randomized controlled study to assess diagnostic yield for malignant biliary strictures with newer variety of biliary brush
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To identify the sensitivity and applicability of a newer cytology brush for tissue sampling of biliary strictures.
研究概览
简要总结
Biliary strictures are a known association with many neoplastic and inflammatory diseases of the bile duct, pancreas and ampulla.Differentiating the benign from malignant strictures is essential for a proper treatment and follow- up of the patient.Though radiological techniques like ultrasonography, Computer Tomography, Endoscopic Ultrasound and Magnetic Resonance Cholangio Pancreatography (MRCP) can diagnose the strictures, they are not sufficient in differentiating the benign from malignant strictures.Brush cytology has a high specificity , but its drawback is the lower sensitivity rates. New biliary brush models were proposed in order to increase the sensitivity. Some models provided a better diagnostic yield while others did not.There are no published randomized prospective studies comparing the older brush with newer ones (with respect to the newer brushes in market as of 2011). Also, no studies have been proposed in India based on the newer biliary brushes available in the market. The present randomized controlled study will address these issues and will compare the older biliary brush with a newer one.
This will be a randomized, participant and outcome assessor blinded, active controlled, prospective study.
Patients with high risk for malignant biliary strictures will be studied. They include patients presenting to the gastroenterology department with features of cholestatic jaundice and clinical diagnosis of cholangiocarcinoma or stricture in common bile duct and those with elevated serum alkaline phosphatase and elevated serum total bilirubin. Biliary brushing in the intervention group will be performed with a newer variety of biliary brush (9 Fr wire-guided cytology brush (Infinity sampling device, US Endoscopy). It has a combination of soft and stiff bristles and hypothesized for better tissue acquisition).
Biliary brushing in the comparator group will be performed with wire guided "RX Cytology Brush by Boston Scientific". It measures 2.1 mm X 2.7mm (8 Fr)
The study will recruit 52 participants with 26 each in the intervention group and in the comparator group.
After obtaining consent from the patient, he/ she will be subjected to Endoscopic Retrograde Cholangio Pancreatography (ERCP). The common bile duct will be visualized under flouroscopy. The presence of stricture in common bile duct will be confirmed. The biliary brush will be supplied to the endoscopist by an assistant. The assistant will pick the relevant type of biliary brush based on the randomized code. The assistant will not be a part of the study. Biliary brushungs will be obtained from the common bile duct. The biliary brush will be retracted and will be placed in a sterile plastic continer filled with Cytolyt solution (methanol). The tip of the brush with bristles will be cut and will also be placed in the solution. Cell block will be prepared and will be analyzed by the pathologist. The pathologist will be blinded regarding the type of biliary brush used for that patient.
The sensitivity, specificity, positive predictive value and negative predictive value will be calculated for both the randomized groups. Analysis will be done based on percentages, chi square test and other relevant tests of significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Biochemical evidence of cholestasis a.Increase of Alkaline Phosphatase greater than three times the upper normal limit And / or b.Serum direct bilirubin greater than 2.0 mg per dl OR 2.Extra hepatic bile duct stricture without discrete mass on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)or Magnetic resonance Cholangio Pancreatography (MRCP).
- •AND 3.Documented extra hepatic biliary stricture during the Endoscopic Retrograde Cholangio Pancreatography (ERCP).
排除标准
- •1.Patients unwilling to participate in the trial 2.Inability to undergo standard ERCP (post surgical anatomy, other contraindications for ERCP) 3.No clinical suspicion for malignancy 4.CT or MRI scan showing an associated mass 5.Pregnancy, lactation 6.Children less than 12 yrs of age and adults greater than 90 years of age (both exclusive) 7.Endoscopically visible peri- ampullary tumor 8.Strictures not permitting the passage of guide wire or biliary brush 9.Previous brushing or placement of biliary stent.
- •10.Co- morbid conditons like chronic pancreatitis, Ampullary neoplasm, Carcinoma pancreas, Carcinoma Gall bladder,Hepatocellular carcinoma, metastatic disease with extrabiliary or unknown primary tumour, benign hepatic masses 11.Any ERCP evidence of bile duct compression 12.Postoperative, traumatic and idiopathic biliary strictures.
结局指标
主要结局
To identify the sensitivity and applicability of a newer cytology brush for tissue sampling of biliary strictures.
时间窗: Each patient will be followed up after the procedure and at the end of six months after randomization
The sensitivity, specificity, positive predictive value and negative predictive value will be calculated for both the randomized groups.
时间窗: Each patient will be followed up after the procedure and at the end of six months after randomization
Analysis will be done based on percentages, chi square test and other relevant tests of significance.
时间窗: Each patient will be followed up after the procedure and at the end of six months after randomization
次要结局
- To compare the percentage of patients diagnosed with malignant biliary stricture between newer and older variety of biliary btush(The pathology report after the procedure is performed will be studied for this outcome)