EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures. A Multi-centred Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 6
- 主要终点
- stent patency rate
研究概览
简要总结
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain.
The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
详细描述
Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. Malignant biliary obstruction is traditionally palliated with ERCP with metallic stent insertion. However, these stents are prone to obstruction due to tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required.
Recently, ECDS has been described as an alternative to percutaneous biliary drainage in patients with failed ERCP. The procedure is also associated with potential advantages as compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old with informed consent
- •Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- •Inoperability by staging, comorbidities or patient wishes
- •Distal tumors 2cm away from the portal hilum
- •Bilirubin > 50umol/L at diagnosis
排除标准
- •Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
- •Presence of main portal vein thrombosis
- •Prior SEMS placement
- •Intraductal papillary mucinous carcinomas
- •Prior Billroth II or roux-en Y reconstruction
- •History of bleeding disorder or use of anticoagulation
- •Child's B/C cirrhosis
- •Pregnancy
- •Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
- •Presence of other malignancy
- •Life expectancy < 3months
结局指标
主要结局
stent patency rate
时间窗: 1-year
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
次要结局
- Clinical success(1 year)
- Technical success(1year)
- Adverse events(30 days)
研究者
Anthony Teoh
Honorary Associate Professor
Chinese University of Hong Kong