NL-OMON38261
Completed
Not Applicable
Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis: ESCAPE - ESCAPE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chronic pancreatitis
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 88
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Not specified
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