The Role of Roux-en-Y Hepaticojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity: an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- The incidence of stones, including residual and recurrent stones, within three years postoperatively.
研究概览
简要总结
Objective: Evaluate the role of Roux-en-Y hepaticojejunostomy (RYHJ) in hepatolithiasis patients with sphincter of Oddi laxity (SOL).
Summary Background Data: Hepatolithiasis poses high risks of residual, recurrence, and re-intervention. SOL significantly impacts this condition. RYHJ has been recommended for hepatolithiasis concomitant SOL but without prospective evidence.
Methods: This is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent SOL. Patients were randomly assigned (1:1) to undergo RYHJ or not. The primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. Secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. The analyses followed the intention-to-treat principle.
详细描述
Hepatolithiasis (HL) is prevalent in East Asia, especially in China. While this condition results from multiple etiological factors, obstructive cholangitis is usually the main cause. In our clinical experience, the investigators have found few cases with obstruction of the common bile duct or sphincter of Oddi; to the contrary, almost half of our clinical cases showed sphincter of Oddi laxity (SOL). SOL results in reflux of duodenal fluid and Escherichia coli (E. coli) infection, which lead to the formation of stones in the biliary tract. Thus, HL tends to recur in SOL patients. For these patients, Roux-en-Y choledochojejunostomy(choledochojejunostomy with an anti-reflux ansa intestinalis) may be the most promising therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 80 years
- •diagnosed with SOL during operation
- •suitable for a radical surgery including RYHJ
- •hopeful to clear stones via operation or combined with subsequent choledochoscopy
- •provided written informed consent
- •willing to complete a 3-year follow-up
- •An intraoperative diagnosis of SOL was established if the rhythmic contraction and relaxation of the sphincter of Oddi were not observed under choledochoscope and the flexible choledochoscope (CHF-P20, external diameter, 4.9 mm; Olympus, Tokyo, Japan) could navigate smoothly to the duodenum through the sphincter of Oddi without any pre-dilation interventions.
排除标准
- •with imaging evidences of tumor preoperatively
- •had congenital biliary malformations
- •had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy
结局指标
主要结局
The incidence of stones, including residual and recurrent stones, within three years postoperatively.
时间窗: A three-year postoperative period
The term "stone occurrence" pertained to the identification of any bile duct stones with the most reliable imaging modality available during the follow-up period. "Stone residual" described a patient in whom stones were detected during the initial follow-up examination, while "stone recurrence" referred to a patient who exhibited no stones at the first follow-up visit but subsequently presented with stones during later follow-up assessments.
次要结局
- Invasive re-interventions for stones and related complications(3-year follow-up period)
- Postoperative hospital stays(perioperation)
- Medical expenses(perioperation)
- Unplanned readmission within 30 days postoperatively(perioperation)
- Major complications(perioperation)
- Episodes of cholangitis(3-year follow-up period)
研究者
TingBo Liang
Professor
Zhejiang University