A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 主要终点
- stone recurrence rate
研究概览
简要总结
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.
详细描述
Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.
Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of the surgeons and patients is not feasible due to the obviously different characteristics of the two types of biliary drainage.
Investigator and outcome assessors will be blinded to the trial intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age age between 18 and 70 years
- •Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation
- •Achieved removing the focus, extraction of stones and correction of stricture during the operation
- •Written Informed consent
- •Willingness for complete 3-year follow-up.
排除标准
- •Participation in concurrent intervention trials with interference of outcome of this study
- •Associated tumor
- •Diagnosed as sphincter of oddi complete loss of function or normal
- •Underwent choledochojejunostomy at past
- •Lack of compliance
结局指标
主要结局
stone recurrence rate
时间窗: 3 years
A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
biliary stricturer rate
时间窗: 3 years
Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
Cholangitis rate
时间窗: 3 years
The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)
次要结局
- quality of life grading(3 years)
- sphincter of oddi function(an expected average of 120 minutes)
- Mortality(90 days)
- Biliary leakage(90 days)
- total bilirubin(90 days)
研究者
xpgeng
professor
The Second Hospital of Anhui Medical University