Long-duration (3 Minutes) Endoscopic Papillary Balloon Dilation Versus Endoscopic Sphincterotomy in Patients With a Naive Major Papilla and Small- to Medium Sized Biliary Stones: Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- rate of adverse event
研究概览
简要总结
Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. However, recent meta-analyses indicate that short EPBD duration increases the risk of post-ERCP pancreatitis, and EPBD with adequate duration has a similar pancreatitis risk and a lower overall complication rate compared with EST for choledocholithiasis.
Therefore, this study aim to compare long-duration EPBD vs EST in the treatment of extrahepatic biliary stones.
详细描述
Gallstones occur in 10%-15% of adults in the United States and are the most common and costly digestive disorder. Concomitant bile duct stones occur in up to 15% of persons with symptomatic gallstones. Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy is the standard treatment for removal choledocholithiasis. The biliary sphincter is permanently ablated by sphincterotomy. Enteric-biliary reflux occurs with bacterial colonization, increased bile lithogenicity, contamination with cytotoxins, and chronic inflammation of the biliary system. Endoscopic papillary balloon dilation (EPBD) has become an option for removal of stones 1 cm or smaller in size. Advantages of EPBD over EST include a decreased risk of post-ERCP bleeding as well as a decreased risk of stone recurrence and cholangitis. Although a short dilation duration (≤1 minute) was previously advocated, a study that performed EPBD for 1 minute observed a 15.4% risk of post-ERCP pancreatitis with 2 cases of mortality. European Society of Gastrointestinal Endoscopy guideline recommends that the duration of EPBD should exceed 2 minutes because long-duration EPBD (>1 minute) is preferred over short-duration EPBD (≤1 minute) with better outcomes. A meta-analysis of RCTs showed that the duration of EPBD is inversely associated with the risk of PEP. Previous RCTs comparing outcome between EPBD and EST used short EPBD duration between 25 seconds and 1 minute, and there has been no comparison of outcome between EST and long-duration EPBD. The aim of this study was to compare the early and long term outcomes of patients treated with long duration balloon dilation or sphincterotomy for extraction of bile duct stones in a randomized, multicenter fashion involving a broad spectrum of practices.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients were invited to participate by the investigators or research staff if they were at least 18 years old,
- •patients who had known or suspected choledocholithiasis
排除标准
- •active acute pancreatitis
- •septic shock,
- •coagulopathy (international normalized ratio >1.2, partial thromboplastic time greater than twice that of control),
- •platelet count <50,000 x 103/uL,
- •anticoagulation therapy within 48 hours of the procedure,
- •stone diameter > 8 mm,
- •bile duct diameter >15 mm, prior sphincterotomy,
- •need for precut sphincterotomy for biliary access,
- •biliary stricture,
- •Billroth II or Roux-en-Y anatomy,
- •periampullary malignancies,
- •primary sclerosing cholangitis, pregnancy,
- •and inability to give informed consent
研究组 & 干预措施
long duration EPBD group
Balloon dilation was performed using wire-guided hydrostatic balloon catheters. An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy. Stones were removed by standard techniques, including balloon or basket catheters.
干预措施: long duration EPBD (Procedure)
long duration EPBD group
Balloon dilation was performed using wire-guided hydrostatic balloon catheters. An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy. Stones were removed by standard techniques, including balloon or basket catheters.
干预措施: EST (Procedure)
endoscopic sphincterotomy (EST) group
After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage.
干预措施: long duration EPBD (Procedure)
endoscopic sphincterotomy (EST) group
After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage.
干预措施: EST (Procedure)
结局指标
主要结局
rate of adverse event
时间窗: up to 1 month after ERCP
Number of participants with treatment-related adverse events
次要结局
- direct cost(within 30 day after ERCP)
- adverse event (pancreatitis)(up to 1 month after ERCP)
- recurrence of choledocholithiasis(more than 3 year follow-up)
- the stone clearance rate at the index ERCP(during ERCP)
- adverse event (bleeding)(up to 1 month after ERCP)
- adverse event (cholangitis)(up to 1 month after ERCP)
研究者
Jun Ho Choi
Assistant Professor
Dankook University