Optimising EUS-guided Choledochoduodenostomy With Lumen Apposing Metal Stent With Stent in Stent Placement: a Randomised Study Between Double Pigtail Stent and Fully Covered Self-Expanding Metal Stent. The Opti-LAMS Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the incidence of stent dysfunction (defined as recurrent jaundice and/or cholangitis) in patients with malignant biliary obstruction receiving FCSEMS vs DPS stent-in-stent through LAMS
研究概览
简要总结
This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain.
A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked.
To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents:
- A plastic stent (double pigtail stent or DPS)
- A metal stent (fully covered self-expanding metal stent or FCSEMS)
The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work.
The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Age ≥18 years.
- •Radiologically or histologically proven malignant distal bile duct obstruction with unresectable or metastatic disease, including those who have already failed ERCP
- •Indication for biliary drainage with presence of obstructive jaundice biochemically and dilated biliary system on imaging.
- •Informed consent provided.
- •Common bile duct (CBD) size of at least 12mm on EUS imaging
排除标准
- •Previous biliary stenting or surgery precluding EUS-CDS.
- •Inability to provide informed consent.
- •Pregnancy.
- •Significant coagulopathy that is not correctable.
- •Futility of intervention e.g. pre-terminal patients
研究组 & 干预措施
Fully covered self expanding metal stent (FCSEMS) within LAMS
In those randomised to FCSEMS, size will depend on the size of the LAMS with a 6mm LAMS to be stented with 8mm diameter FCSEMS and an 8mm LAMS to be stented with a 10mm FCSEMS, 4cm or 6cm length. The aim is to have at least 3cm of FCSEMS in the duodenal lumen If unable to place FCSEM through LAMS, crossover to DPS is allowed with plan for both intention to treat and per protocol analysis to be undertaken after completion of the study
干预措施: Fully covered self expanding metal stent (FCSEMS) within LAMS (Device)
Double pigtail stent (DPS) within LAMS
In those randomised to DPS, a double pigtail will be placed through the LAMS. The size of the stents will be left to the discretion of the proceduralist though 7Fr calibre with 7cm length is the recommended size
干预措施: Double pigtail stent (DPS) within LAMS (Device)
结局指标
主要结局
To compare the incidence of stent dysfunction (defined as recurrent jaundice and/or cholangitis) in patients with malignant biliary obstruction receiving FCSEMS vs DPS stent-in-stent through LAMS
时间窗: 26 weeks
次要结局
- Technical success of LAMS placement.(1 day)
- Re-intervention rate(26 weeks)
- Technical success of second stent-in-stent placement(1 day)
- Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes).(weeks 1, 2, 4, 12, and 26)