Evaluation of Different Modalities (Surgery and Endoscopy) in Management of Indeterminate Lower Common Bile Duct Stricture
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of patients who are successfully treated of CBD strictures by endoscopy or by surgery
研究概览
简要总结
Evaluate the lower indeterminate CBD strictures trying to reach possible diagnosis by all available methods i.e brush cytology ,bile aspirate cytology , tissue biopsy ,imaging studies and laboratory work up then treatment of the patient either endoscopically or surgically according to the etiology.
详细描述
Aim of the work Evaluate the lower indeterminate CBD strictures trying to reach possible diagnosis by all available methods i.e brush cytology ,bile aspirate cytology , tissue biopsy ,imaging studies and laboratory work up then treatment of the patient either endoscopically or surgically according to the etiology.
Approvals and consents This study will be done after obtaining approval by the medical ethics committee of sohag faculty of medicine.A written informed consent will be obtained from all participants before being enrolled in the study and prior to performing the procedure .the study will be registered in www.clinicaltrials.gov .
Clinical presentation The common presentation is one or more of Charcot's triad ;Jaundice ,Fever and Pain with itching and dark urine and pale clay stool Also the patient may be presented by Pain in the upper right side of the abdomen (biliary pain) ,nausea and vomiting .
By examination yellowish discoloration of skin and sclera and mucous membrane , and itching marks.
Accidental diagnosis of indeterminate stricture may be discovered in asymptomatic patient during imaging study (MRCP , US), or during ERCP for any other cause i.e common bile duct stone after stone extraction accidently a distal CBD stricture
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •above age of 20 years old
- •patients presented with jaundice , pain and fever due to lower common bile duct stricture evident by abdominal imaging (Abdominal US ,MRCP) and confirmed by endoscopic retrograde cholangiopancreatography ( ERCP)
- •patients presented to sohag university hospital.
排除标准
- •Already diagnosed lower CBD strictures i.e known cause like visible pancreatic mass with visible metastasis or common bile duct stones.
- •Coagulopathy INR more than 1.5 or thrombocytopenia platelet less than 50,000/ml.
- •Proximal common bile duct stricture "above level of cystic duct".
结局指标
主要结局
number of patients who are successfully treated of CBD strictures by endoscopy or by surgery
时间窗: follow up of the patient for 6 - 9 months
dilatation or resection and shunt operation of CBD strictures allow continuity of the biliary system with good bile drainage
reach a proper algorithm or scheme for management of the CBD stricture
时间窗: follow up of the patient for 6 - 9 months
reach a proper algorithm or scheme to help in diagnosis of CBD strictures also, choose the proper method for treatment according to the nature and criteria of the CBD stricture
次要结局
- number of patients diagnosed by each method to measure accuracy and sensitivity of each method used in the study in diagnosis of biliary strictures(follow up of the patient for 6 - 9 months)
研究者
Mohamed Elsayed Abdelaal
assistant lecturer of general surgery sohag faculty of medicine
Sohag University