跳至主要内容
临床试验/NCT05155475
NCT05155475已完成不适用

Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies: a Multicenter Prospective Study (ECCO Trial)

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Evaluation of the common bile duct size

研究概览

简要总结

To assess the size of the common bile duct in a large cohort of patients with jaundice following a malignant tumor of the head of the pancreas or the distal bile duct receiving a diagnostic EA for biopsy and / or for evaluation of tissue resectability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with jaundice and an injury to the head of the pancreas recommended for EUS-guided tissue acquisition or staging
  • Patients with jaundice and distal CBD lesion suggestive of cholangiocarcinoma or Vater's ampulla carcinoma recommended for EUS-guided tissue acquisition or staging
  • Serum bilirubin level ≥ 3 mg / dl
  • Age ≥ 18 years old
  • Subject affiliated or beneficiary of a social security scheme.
  • Subject having been informed of this study and having given his no objection

排除标准

  • Presence of altered anatomy due to previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
  • Sphincterotomy performed previously, plastic biliary stent or metal stent placement
  • Percutaneous drainage of the bile ducts performed previously
  • Pregnant, breastfeeding or parturient woman
  • Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; hospitalized without consent.

结局指标

主要结局

Evaluation of the common bile duct size

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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