Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis
Status:
Completed
Trial end date:
2018-05-31
Target enrollment:
Participant gender:
Summary
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a commonly performed endoscopic
procedure used to treat pancreato-biliary pathology. Acute pancreatitis or post-ERCP
pancreatitis (PEP), is the most common major complication of ERCP, which is reported to occur
in 2-10% of patients overall (ranging from 2-4% in low risk patients up to 8-40% in high-risk
patients). Hydration is a mainstay of treatment for acute pancreatitis, independent of
etiology. Aggressive hydration has also been shown to decrease incidence of PEP. Rectal
NSAIDs, including Indomethacin, has a proven role in prevention of PEP. Though both
aggressive hydration and rectal indomethacin are efficacious in preventing PEP, there is no
head to head trial comparing the efficacy of these two therapeutic modalities. Thus, the aim
is to determine whether aggressive intravenous peri-procedural hydration or high dose rectal
indomethacin immediately after ERCP decrease the incidence of PEP. The investigator's
hypothesis is that prophylactic treatment with aggressive intravenous hydration is not
inferior to rectal indomethacin in preventing PEP.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research