Does Rectal Indomethacin Eliminate the Need for Prophylactic Pancreatic Stent Placement in Patients Undergoing High-Risk ERCP? Post hoc Efficacy and Cost-Benefit Analyses Using Prospective Clinical Trial Data

Abstract

OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

The incidence of post-ERCP pancreatitis is not reduced in patients given intravenous ketorolac for post-procedural abdominal pain

“…In this last case, it is still debated whether prophylaxis with NSAIDs plus a stent is better than NSAIDs or the stent alone [36][37][38]. A recent trial suggests that prophylactic rectal indomethacin could replace prophylactic pancreatic stent in patients undergoing high risk ERCP, potentially improving clinical outcomes and reducing healthcare costs [34].…”

Post-ERCP Pancreatitis: Mechanisms, Risk Factors, and Prevention

“…In this study, rectal indomethacin was associated with a 7.7% absolute risk reduction in post-ERCP pancreatitis rates. In post hoc analyses, rectal indomethacin appeared to be more efficacious than prophylactic pancreatic stents, and cost-benefit analysis favored a strategy of indomethacin alone for post-ERCP pancreatitis prevention [62]. The post hoc results are best viewed as hypothesis generating, and further investigation is necessary before a strategy of rectal NSAIDs without pancreatic duct stenting can be recommended for post-ERCP pancreatitis prevention.…”

“…Experimental data supporting their beneficial effects in acute pancreatitis along with their low cost and ease of administration have spurred a number of clinical trials evaluating their efficacy in prevention of PEP [60][61][62][63][64][65].…”

Az endoszkópos retrográd cholangiopancreatographiát követő heveny hasnyálmirigy-gyulladás megelőzése

“…Betegeink 'post hoc' elemzése azt mutatta, hogy a 100 mg-os indometacin végbélkúp sem a szív-és keringési eredetű halá-lozást [45], sem a sphincterotomia utáni vérzés gyakoriságát nem növelte meg, még a napi 100 mg szalicilátot szedőkben sem [46]. Úgy tűnik, hogy az indometacin helyettesíti vagy akár fölülmúlja a PEP megelőzésében a hasnyálmirigy-vezetékbe profi laktikusan behelyezett műanyag stentet [47,48], és effektív, ha a hasnyálmi-rigystent behelyezése sikertelen [49]. Az olcsó indometacin-vagy a diclofenackúp költséghatékonysága kiemelkedő [50].…”