跳至主要内容
临床试验/NL-OMON49021
NL-OMON49021尚未招募不适用

Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC) - Non-Complex Biliary Stones DSC vs. ERC RCT

Boston Scientific Corporation0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
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

入排标准

年龄范围
18 至 99(—)

入选标准

  • * 18 years or older
  • * Abdominal pain consistent with choledocholithiasis
  • * Abnormal LFTs
  • * Non-complex biliary stone disease

排除标准

  • * Potentially vulnerable subjects, including but not limited to pregnant women
  • and subjects in whom an endoscopic procedure is contraindicated.
  • * Location of the stones in intrahepatic ducts, cystic duct or proximal to
  • * Bile duct stricture noted distal to stone on MRCP, which would make
  • extraction without lithotripsy impossible.
  • * Ongoing cholangitis at time of randomization, manifested by fever with
  • tachycardia and hypotension or evidence of pus at the ampulla
  • * Patients with prior biliary sphincterotomy
  • * Patients with Primary Sclerosing Cholangitis (PSC)
  • * Acute pancreatitis
  • * Surgically altered gastro-duodenal luminal anatomy other than prior Billroth
  • I Reconstruction
  • * Coagulopathy or ongoing need for anti-coagulation

研究者

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