Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- Re-intervention rate
研究概览
简要总结
Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, although data in the literature are discordant. Therefore the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After metallic biliary stent insertion, enrolled patients will be followed for 12 months.
详细描述
Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use in malignant biliary obstructions.
Therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).
Then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered:
- T1: it will start after stent insertion. The biliary drainage will be considered effective, according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and UNFIT Group.
FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study once every three months.
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
- •The patients who had malignant biliary obstruction with a estimated survival >4 months
排除标准
- •The patients who had resectable biliary malignancy
- •The patients who had hilar obstruction
- •The patients who had duodenal obstruction
- •The patients who had International Normalized Ratio (INR)>1.5
- •The patients who did not give informed consent
- •The patients who had technically difficult structure for Endoscopic retrograde cholangiopancreatography (ERCP)
结局指标
主要结局
Re-intervention rate
时间窗: 12 months
Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.
次要结局
- Evaluation of patency, migration and adverse events rate(12 months)
研究者
Santi Mangiafico
Medical Doctor
Azienda Ospedaliero-Universitaria di Modena