跳至主要内容
临床试验/NCT02114320
NCT02114320已完成3 期

Multicenter Study of EUS-guided Biliary Drainage Using Partially Covered With a Dedicated Introducer or Fully Covered Antimigration Metallic Stents

Asan Medical Center3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
32
试验地点
3
主要终点
Technical success rate and procedural time of EUS-BD using metallic stents

研究概览

简要总结

Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.

Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.

Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.

详细描述

We investigated the efficacy and safety of EUS-BD using partially covered (hybrid) metallic stent with a dedicated introducer for EUS-BD, or fully covered antimigration metallic stents in malignant biliary obstruction after failed conventional ERCP as a prospective multicenter study.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • malignant biliary obstruction
  • Inoperable state
  • age > 18 yrs
  • failed primary ERCP

排除标准

  • uncontrolled coagulopathy
  • refuse to this study enrollment

结局指标

主要结局

Technical success rate and procedural time of EUS-BD using metallic stents

时间窗: six months

Measure the successful rate of biliary drainage using metallic stents and procedural time

次要结局

  • Complication rate of EUS-BD using metallic stents(six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Do Hyun Park

Dr

Asan Medical Center

研究点 (3)

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