Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis (ESCAPE): a multi-centre randomised controlled trial

Academic Medical Centre Amsterdam (Netherlands)0 sites88 target enrollmentMarch 25, 2011

Overview

Registry

who.int

Start Date

March 25, 2011

End Date

July 1, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Academic Medical Centre Amsterdam (Netherlands)

•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

•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)