A recent large-scale randomized controlled trial (RCT) demonstrated
that rectal indomethacin administration is effective in addition to
pancreatic stent placement (PSP) for preventing post-endoscopic retrograde
cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We
performed a post hoc analysis of this RCT to explore
whether rectal indomethacin can replace PSP in the prevention of PEP and to
estimate the potential cost savings of such an approach.
We retrospectively classified RCT subjects into four prevention
groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone,
and (4) the combination of PSP and indomethacin. Multivariable logistic
regression was used to adjust for imbalances in the prevalence of risk
factors for PEP between the groups. Based on these adjusted PEP rates, we
conducted an economic analysis comparing the costs associated with PEP
prevention strategies employing rectal indomethacin alone, PSP alone, or the
combination of both.
After adjusting for risk using two different logistic regression
models, rectal indomethacin alone appeared to be more effective for
preventing PEP than no prophylaxis, PSP alone, and the combination of
indomethacin and PSP. Economic analysis revealed that indomethacin alone was
a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy
employing rectal indomethacin alone could save approximately $150 million
annually in the United States compared with a strategy of PSP alone, and $85
million compared with a strategy of indomethacin and PSP.
This hypothesis-generating study suggests that prophylactic rectal
indomethacin could replace PSP in patients undergoing high-risk ERCP,
potentially improving clinical outcomes and reducing healthcare costs. A RCT
comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.