Background
Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).
Methods
In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.
Results
A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03).
Conclusions
Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)
In an analysis of a large cohort of subjects with IBD, we found a significant association between symptoms of depression or anxiety and clinical recurrence. Patients with IBD should therefore be screened for clinically relevant levels of depression and anxiety and referred to psychologists or psychiatrists for further evaluation and treatment.
Acute cholangitis is a potentially life-threatening systemic disease resulting from a combination of infection and obstruction of the biliary tree, secondary to different underlying etiologies. Common causes of cholangitis (eg, gallstones, benign and malignant biliary strictures) are well known. However, others (eg, immunoglobulin-G subclass-4-related sclerosing cholangitis) have been described only recently, are still under evaluation, and need to gain broader attention from clinicians. The diagnosis of acute cholangitis is based on clinical presentation and laboratory data indicating systemic infection, as well as diagnostic imaging modalities revealing signs of biliary obstruction and possibly an underlying etiology. The clinical presentation varies, and initial risk stratification is important to guide further management. Early medical therapy, including fluid resuscitation and appropriate antibiotic coverage, is of major importance in all cases, followed by a biliary drainage procedure and, if possible, definitive therapy of the underlying etiology. The type and timing of biliary drainage should be based on the severity of the clinical presentation, and the availability and feasibility of drainage techniques, such as endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC), and open surgical drainage. ERCP plays a central role in the management of biliary obstruction in patients with acute cholangitis. Endoscopic ultrasound-guided biliary drainage recently emerged as a possible alternative to PTC for second-line therapy if ERCP fails or is not possible.
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.
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