Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis: ESCAPE
- Conditions
- chronic pancreatitis1001796910017998
- Registration Number
- NL-OMON38261
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is pain assessed with the Izbicki pain score.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are severe complications, mortality, cost-effectiveness,<br /><br>quality of life, pancreatic insufficiency, alternative pain scales, hospital<br /><br>admissions and number of performed interventions.</p><br>