Comparative Study of Three Common Bile Duct Closure Techniques After Choledocholithotomy: Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Postoperative bile leak
研究概览
简要总结
This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.
详细描述
At present, the commonest available options for CBD closure include repair over T-tube drain, primary closure, and repair after antegrade biliary stenting. All three methods present specific technical performance features, require different postoperative management protocols, and are charged with specific morbidity related to the procedure and therefore should not be considered the same procedure in the context of CBDE.
Repair over T-tube is the traditional surgical technique. It has many advantages as post-operative distal CBD decompression, trans-tubal cholangiography, and availability of retained CBD stones extraction. However, it has several potential complications up to 10% of patients. The most frequent complications are bile leakage, tract infection, T-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. It also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. Primary closure of CBD has been described in the literature to overcome these adverse consequences of the T-tube. However, it has many potential complications as a potential bile leak and CBD stricture, which may occur due to papillary edema and insufficient bile duct expansion. There are conflicting results regarding significant differences in the morbidity and mortality between primary closure and T-tube drainage. There is no conclusive evidence displaying whether primary closure is better or worse than T-tube drainage after CBD exploration.
Using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. Although there are some available drainage options after CBDE, a consensus on the optimal drainage is yet to be reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CBD stones
- •age from 20 to 80,
- •CBD > 0.8 cm and < 2.5 cm,
- •American Society of Anesthesiologists (ASA) grade I, II or III,
- •agreement to randomization and complete the study requirement.
排除标准
- •acute suppurative cholangitis,
- •acute biliary pancreatitis,
- •biliary malignancy,
- •biliary malformation,
- •distal CBD stenosis and or obstruction,
- •trans-cystic stone extraction,
- •explorations followed by choledochojejunostomy and choledochoduodenostomy.
研究组 & 干预措施
Antegrade stenting
Closure of common bile duct over antegrade biliary plastic stent
干预措施: Primary closure (Procedure)
T tube drainage
Closure of common bile duct after choledocholithotomy over T tube
干预措施: Primary closure (Procedure)
T tube drainage
Closure of common bile duct after choledocholithotomy over T tube
干预措施: Antegrade stenting (Procedure)
Primary closure
Primary closure of the common bile duct after choledocholithotomy
干预措施: T tube drainage (Procedure)
Primary closure
Primary closure of the common bile duct after choledocholithotomy
干预措施: Antegrade stenting (Procedure)
Antegrade stenting
Closure of common bile duct over antegrade biliary plastic stent
干预措施: T tube drainage (Procedure)
结局指标
主要结局
Postoperative bile leak
时间窗: 3rd to 7th postoperative day
The discharge of fluid via intra-abdominal drain or intra-abdominal fluid with bilirubin concentration at least 3 times the serum bilirubin concentration measured at the same time on or after the 3rd postoperative day, or as the need for radiologic or surgical intervention because of biliary collections.
Post operative biliary stricture
时间窗: 6 month
The segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Recurrent biliary stones
时间窗: 6 month
Common bile duct stone after 6 months of the procedure
次要结局
- Visual analogue score(3 days)
- The number of patients need postoperative opioid(3 days)
- Return to normal activity(30 days)
- Postoperative bilirubin level(7 days)
- Total cost of treatment(Through study completion, average 6 month)
- Hospital stays(10 days)
- Drain-carried time(20 days)
- Type of re-intervention(6 month)
研究者
Mohammed Ahmed Omar
Associate professor of HPB surgery
South Valley University
