Pancreatitis Relapsing Clinical Trial
Official title:
Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial
Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial
Acute pancreatitis (AP) is the 3rd cause of hospital admission due to gastrointestinal
disease. Approximately 20% of the patients will relapse after a first episode of AP. The low
frequency of relapse in biliary AP is due to the high effectiveness of cholecystectomy but a
first episode of AP due to alcoholic or other etiologies is associated with relapse in one
every four patients. Currently, besides counselling for alcohol and tobacco abstinence, there
is no specific medical treatment that changes the natural history of recurrent AP. Recurrent
AP is an intermediary stage in the pathogenesis of chronic pancreatitis (CP) and a subset of
recurrent AP patients during their natural course transition to CP (one every three
patients). Forty-five percent of patients with CP experience intermittent flares of pain.
Simvastatin has been associated to a decrease in the incidence of AP in a population-based
study (Wu et al, Gut. 2015) and in a meta-analysis of randomized controlled trials (Preiss et
al, JAMA 2012).
The main aim of SIMBA (SIMvastatin in the prevention of recurrent pancreatitis, a triple
Blind rAndomized controlled multicenter trial) is to compare the recurrence rate of
pancreatitis in patients with established recurrent pancreatitis (acute pancreatitis and
acute flares in chronic pancreatitis) consuming simvastatin versus placebo.
The secondary aims are 1) to compare in patients with recurrent AP at the end of follow-up
period the progression to chronic pancreatitis on imaging (calcifications and/or dilated
ductal system), as well as endocrine and exocrine pancreatic function; 2) to compare the
severity of recurrent pancreatitis between both treatment arms.
Design: SIMBA is a triple-blind randomized placebo-controlled, parallel-group, superiority
multicenter (27 Spanish centers) trial. This final protocol (version 4) was finished on June
20th 2018.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06124989 -
Machine learnINg for the rElapse Risk eValuation in Acute Biliary Pancreatitis.
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