About this trial
Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Abdominal pain characteristic of AP
Serum amylase and/or lipase ≥ 3 times the upper limit of normal
Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.
Disqualifiers
Onset time >24 hours
Presence of renal dysfunction (serum creatinine > 1.5 *normal upper limit)
Severe liver dysfunction
Active peptic ulcer disease or GI bleeding
Trial design
Parallel
Treatments tested in this trial
Indomethacin SR
DrugIndomethacin SR 50mg given q12h from admission day 1 to day 7
Placebos
DrugSimilar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Treatment groups
Trial outcomes
Primary outcomes
Occurence rate of organ dysfunction caused by acute pancreatitis
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems
Secondary outcomes
Occurence rate of pancreatic necrosis
Accumulation of the key local complication of acute pancreatitis
Incidence rate of ICU admission
Evaluation of critical severe acute pancreatitis
Mortality
The number of deaths during a particular period of time
Other outcomes
Hospitalization cost
Expense of acute pancreatitis
Sponsors and contacts
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