Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Indomethacin SR
  • Placebos

Treatment groups

1,504 Participants
are divided into 2 treatment groups