NL-OMON38261已完成不适用
Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis: ESCAPE - ESCAPE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
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
- •1. Age * 18 years
- •2. Confirmed chronic pancreatitis: according to the following criteria (adapted from the M-ANNHEIM diagnostic criteria):
- •* typical clinical history of chronic pancreatitis (i.e. recurrent pancreatitis or abdominal pain), and:
- •* one or more of the following additional criteria for the diagnosis of chronic pancreatitis:
- •a. Pancreatic calcifications
- •b. Moderate or marked ductal lesions (according to the Cambridge classification) on magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT) or endoscopic ultrasounds (EUS) imaging
- •c. Marked and persistent exocrine insufficiency (defined as: a. pancreatic steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal elastase levels of * 200 micro gram/gram)
- •3. Dilated pancreatic duct: dilated pancreatic duct of * 5 mm (established by MRCP, CT or EUS), with or without enlargement of the pancreatic head
- •4. Presence of moderate, non-debilitating pain. This will be defined as chronic or recurrent abdominal pain sufficiently relieved with non-opioid analgesics;Patients will be eligible for randomization to one of the trial arms when the randomization criteria are met:
- •* In patients with chronic abdominal pain related to chronic pancreatitis: a need to upgrade pain medication from non-opioids to opioid analgesics (opioids needed at least 3 days per week) and persistently needed for at least 2 weeks in a row
- •* In patients with recurrent flare ups of chronic pancreatitis (including episodes of acute on chronic pancreatitis) and pain-free intervals that:
- •- have occurred at least 3 times during one year (i.e. 12 months);
- •- during at least 7 consecutive days;
- •- necessitate opioid use during flare up;
- •- impairs the patient in daily activities.
- •* Informed consent for randomization
排除标准
- •* History of prolonged need of opioids: history for need for strong opioids for CP for a total period over 2 months or a history for need for weak opioids for CP for a total period of 6 months in the last 2 years
- •* Previous pancreatic surgery
- •* Previous endoscopic dilatation or stenting of the pancreatic duct. Patients with previous endoscopic intervention for biliary obstruction, without intervention involving the pancreatic duct, will be eligible for the trial.
- •* 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).
- •* Proven autoimmune pancreatitis (including elevated levels of gamma-globulins (IgG))
- •* Stones and strictures exclusively located in the tail of the pancreas (defined as to the left of the left border of the vertebra) with relatively normal pancreatic head and corpus.
- •* Fully impacted stones casting the entire main pancreatic duct (from head to tail) and side branches.
- •* Suspected or established pancreatic malignancies
- •* Life expectancy of < 1 year for any reason
- •* Presence of duodenal obstruction necessitating surgery, as judged by the expert panel
- •* Presence of a pseudocyst larger than 6 cm necessitating intervention, as judged by the expert panel
- •* 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)
- •* Pregnancy
研究者
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