To Evaluate the Effect of Stenting on Liver Function in Choledocholithotomy Patients.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Liver Function Test (LFT)
研究概览
简要总结
Choledocholithiasis is the 2nd most common complication of gallbladder stone disease. It affects 10-20% of individuals with symptomatic gallstones and 5% of those with asymptomatic gallstones. To prevent further issues including obstructive jaundice, pancreatitis and cholangitis, CBD stones must be removed. Choledocholithiasis treatment options include open CBD exploration, laparoscopic CBD exploration, and endoscopic retrograde cholangiopancreatography (ERCP), which may be combined with or performed after laparoscopic cholecystectomy (LC).
Choledocholithiasis is a common problem encountered approximately in 10% of asymptomatic patients during cholecystectomy. 1-2% of patients following cholecystectomy will present with a retained stone in a setting where selective cholangiography is not performed.
About 15% of people with gall bladder stone develops stone in CBD. Stones may also be found in the intra- and extrahepatic, and common bile ducts. Typically, they come from the gallbladder and travel through cystic duct. Sometimes they are formed in the ducts and are then called ‘primary duct stones’. They are common in tropics and may be due to secondary infestation of the biliary tree by Ascaris lumbricoides and Clonorchis sinesis.
The consequences of duct stones are either obstruction or infection (cholangitis).
The patient may be asymptomatic or may have symptoms of pain, jaundice and fever.
Signs: tenderness may be elicited in the epigastrium and right hypochondrium.
There are two methods for extraction of CBD stones, either by endoscopic retrograde cholangiopancreatography (ERCP) or surgically, by an open or laparoscopic method.
A good alternative to CBD decompression is the use of internal biliary stent widely used in endoscopic procedures and laparoscopic CBD exploration. Several studies have demonstrated the usefulness of these stents leading to decreased complications, morbidity and cost, as compared to t-tube in laparoscopic CBD exploration.
Prior to the use of stents, the primary treatment for biliary obstruction was surgery, such as choledochojejunostomy or choledochodudenostomy. The endoscopic placement of biliary stents was first introduced in the early 1980s. There was a rapid shift from surgery towards endoscopic retrograde cholangiopancreatography (ERCP) stent placement because of its better mortality and morbidity profile. In 1982, the first 10 French plastic stent was placed into a bile duct. In the late 1980s, self-expandable metal stents (SEMS) were adapted to the biliary tract to improve patency. In 2012, the European Society for Gastrointestinal Endoscopy (ESGE) published guidelines for clinical indications, and selection of stents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in age group of 20 to 60 years Patients of either gender (male/female) Patients with hyperbilirubinaemia in the presence of gallstone disease Patients with controlled hypertension Presence of CBD stones in USG Clinically examined as well as diagnosed patients of Choledocholithiasis Patients willing to sign written consent form.
排除标准
- •Patients with concomitant diseases like pancreatitis, pancreatic pathology causing jaundice, renal failure, malignancy and evidence of ampullary obstruction Patients with bile duct stenosis Pregnant women.
结局指标
主要结局
Liver Function Test (LFT)
时间窗: 60 post operative day
次要结局
- CBC(RFT)
研究者
Shahid Khan
Ajmal Khan Tibbiya College, Aligarh Muslim University
