The Early Surgery versus surgery as last resort for Chronic Pancreatitis-(ESSLaR) trial. - ESSLaR Trial

Department of surgical gastroenterology.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•Inclusion criteria
•Age > 18 years
•typical clinical history of chronic pancreatitis
•â?ª one or more of the following additional criteria for the diagnosis of CP:
•1. Pancreatic calcifications on CT or MRI imaging.
•2. Moderate or marked ductal lesions on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP) imaging.
•3. 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)
•4. Dilated pancreatic duct: dilated pancreatic duct of >= 5 mm, with or without enlargement of the pancreatic head.
•5. Presence of moderate, non-debilitating pain FOR EARLY SURGERY GROUP
•6 Presence of debilitating pain not amenable to strong opiods for standard surgery group

•Exclusion criteria
•1.History of prolonged need of opioids- weak opioids for CP for a total period of 6 months in the last 2 years.
•2.Previous pancreatic surgery
•3.Previous endoscopic dilatation or stenting of the pancreatic duct /biliary
•4.Autoimmune pancreatitis
•5.Stones and strictures exclusively located in the tail of the pancreas
•6.Fully impacted stones casting the entire main pancreatic duct (from head to tail) and possibly side branches
•7.Suspected or confirmed pancreatic malignancy
•8.Life expectancy of < 1 year for any reason
•9.Presence of duodenal obstruction necessitating surgery.
•10.Presence of a pseudocyst larger than 6 cm necessitating intervention.
•11.severe portal hypertension due to occluded portal vein
•12.Pregnancy

发起方

Department of surgical gastroenterology.