NL-OMON32422尚未招募3 期
Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancreatic necRosis (CONDOR trial): a prospective randomised controlled trial - CONDOR
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 58
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
- •*Presence of a single (>6cm), large, well defined (peri)pancreatic fluid collection on contrast-enhanced computed tomography (CECT) or a similar fluid collection on MRI also containing necrotic material larger than 1 cm in diameter.
- •*The presence of at least one of the following persistent symptoms, suspected to be caused by the fluid collection, despite of conservative treatment of minimally 6 weeks after onset of acute necrotizing pancreatitis: Severe abdominal pain, Gastric outlet obstruction or obstructive jaundice
- •* Window for transluminal endoscopic debridement
- •* Age equal to or above 18 years
- •* Written informed consent
排除标准
- •* Infected pancreatic necrosis, defined as the presence of air in the collection on CECT.
- •* Suspected infected necrosis, defined as a rise of two out of three following parameters: >50% increase of leucocytes or CRP or temperature rises above 38,5oC within 72 hours.
- •* New failure of at least one of the following organs: cardiac, pulmonary or renal.
- •* Acute flare-up of chronic pancreatitis
- •* Previous endoscopic (transgastric or transduodenal), percutaneous or surgical drainage of a pancreatic fluid collection
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