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临床试验/ACTRN12621001534875
ACTRN12621001534875招募中未知

To assess the feasibility and safety performance of the novel bio-degradable stent (ARCHIMEDES) in three patient groups: Duct to duct anastomotic strictures, hepatico-jejunal strictures and those that require post-endoscopy retrograde cholangiopancreatography (ERCP) pancreatitis prophylaxis (PEP).

Royal Prince Alfred Hospital0 个研究点目标入组 60 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Clinical criteria (1 required)
  • A. Patients with clinical indication for ERCP with a duct to duct anastomotic stricture or Hepaticojejunal stricture
  • B. Those requiring pancreatic duct stent placement for post ERCP pancreatitis prophylaxis.
  • Other criteria:
  • Symptoms or signs: jaundice, cholangitis
  • Age 18 years old and above
  • Able to give informed consent

排除标准

  • Contra-indication for endoscopy
  • Patients who had undergone any treatment to the stricture in the last 6 months
  • Inability to pass a guidewire through stricture
  • Malignant stricture
  • Multiple concomitant bile duct strictures
  • Stricture length > 8cm
  • Anticoagulant therapy that cannot be discontinued prior to procedure

研究者

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