Lumen apposing metal stents versus Covered tubular self-expanding metal stents for EUS-guided choledochoduodenostomy In Distal malignant biliary obstruction: A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Rates of re-intervention for recurrent biliary obstruction
研究概览
简要总结
The gold standard for the management of malignant distal biliary obstruction (MDBO) has been endoscopic retrograde cholangiopancreatography (ERCP). Despite the advancements in endoscopic accessories and techniques, failure to cannulate may be present in 4-16% cases. In such cases, patients are salvaged with percutaneous transhepatic biliary drainage (PTBD) or surgery. Both salvage modalities have their own shortcomings. An alternative to these which has gained momentum in MBO management has been endoscopic ultrasound guided biliary drainage (EUS-BD). For MDBO, EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy can be done. For EUS-CDS, it is more technically easier and can be done by either tubular metal stents (SEMS) or cautery enhanced lumen apposing metal stents (EC-LAMS). Both these stents has their own set of pros and cons. But which metal stent to prefer (SEMS versus EC-LAMS) for EUS-CDS is still debatable. We hypothesized that, while EC-LAMS and SEMS would be equally effective and safe, the rates of stent dysfunction/block requiring re-intervention would be different between the two arms considering the inherent difference in the design of the two stents. Thus, this study has been planned to compare EC-LAMS versus covered tubular SEMS in EUS-CDS in terms of clinical efficacy, safety, and re-intervention rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •malignant distal biliary obstruction naive/prior ERCP failure or unsuccessful ERCP informed consent.
排除标准
- •hilar or proximal biliary obstruction altered GI anatomy Unfit for endoscopic procedure uncorrectable coagulopathy or thrombocytopenia pregnancy.
结局指标
主要结局
Rates of re-intervention for recurrent biliary obstruction
时间窗: 6 months
次要结局
- 1. Technical success(2. Clinical success)
研究者
Jayanta Samanta
Postgraduate Institute of Medical Education and Research, Chandigarh
