ISRCTN45877994已完成未知
Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis (ESCAPE): a multi-centre randomised controlled trial
Academic Medical Centre Amsterdam (Netherlands)0 个研究点目标入组 88 人开始时间: 2011年3月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23506415 2020 results in: https://www.ncbi.nlm.nih.gov/pubmed/31961419 (added 22/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Registration criteria:
- •1. Age 18 years
- •2. Confirmed chronic pancreatitis: according to the M-ANNHEIM diagnostic criteria
- •3. Dilated pancreatic duct [5 mm, established by magnetic resonance cholangiopancreatography (MRCP), Computerised Tomography (CT) or Endoscopic ultrasound (EUS)], with or without enlargement of the pancreatic head
- •4. Presence of moderate, non-debilitating pain. This will be defined as chronic abdominal pain (present for at least 3 months) sufficiently relieved with non-opioid analgesics
- •Randomisation criteria (after fulfilling inclusion criteria for registration):
- •1. Need for upgrade from non-opioids to opioid analgesics: newly developed need for opioids analgesics (opioids needed at least 3 days per week) and persistently needed for at least 2 weeks in a row
- •2. Informed consent for randomisation
排除标准
- •1. History of prolonged need of opioids for chronic pancreatitis for a period over 2 months in the last 2 years
- •2. Previous pancreatic surgery
- •3. Previous endoscopic dilatation or stenting of the pancreatic duct
- •4. Episode of biliary obstruction in the last 2 months (defined as jaundice or bilirubine levels 25 micromol / L) or the presence of a stent in the common bile duct (CBD)
- •5. Proven autoimmune pancreatitis (including elevated levels of gamma-globulins (IgG))
- •6. Suspected or established pancreatic malignancies
- •7. Life expectancy of < 1 year for any reason
- •8. Presence of duodenal obstruction necessitating surgery, as judged by the expert panel
- •9. Presence of a pseudocyst larger than 6 cm necessitating intervention, as judged by the expert panel
- •10. Contra-indications for surgery, always evaluated by the expert panel (e.g. American Society of Anesthesiology class IV, severe portal hypertension due to occluded portal vein)
- •11. Pregnancy
研究者
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