There is a high risk of pancreatitis after a diagnostic procedure - ERCP (endoscopic retrograde cholangiopancreatography). ERCP is a procedure that is commonly utilized to treat or diagnose problems of the bile and pancreatic ducts. During an ERCP procedure, a lighted scope is inserted through the mouth while X-ray pictures are taken to check the tubes that drain the liver, pancreas and gallbladder.
A new study by the researchers from the University of Michigan Health System and Indiana University Medical Center finds that the incidence of pancreatitis after ERCP was considerably reduced if patients were administered rectal indomethacin after their procedure. The study is published April 12 in the New England Journal of Medicine.
The authors explained that their findings may lead to a simple treatment that could prevent a condition called post-ERCP pancreatitis, a complication that can affect up to one quarter of all patients who undergo ERCP. Even though this complication has been studied for years, this clinical trial is the first to compellingly show how effectively post-ERCP pancreatitis can be avoided.
An interim analysis that clearly demonstrated the safety and benefit for the initial 602 patients who had enrolled ended early. Eligible patients were randomized to receive two 50-mg indomethacin suppositories or two matching placebo suppositories immediately after ERCP.
The authors say the results of the trial have already altered clinical practice in this field. 9.2% of those who were given indomethacin post-ERCP developed pancreatitis (46% lower chance compared to those on placebo) and 16.9% of those who took a placebo developed pancreatitis.
Most patients (82.3%) were at high risk for post-ERCP pancreatitis because of a clinical suspicion of sphincter of Oddi dysfunction, and more than half had sphincter hypertension, as documented on manometry. Other reasons included a history of post-ERCP pancreatitis, pancreatic sphincterotomy, more than 8 cannulation attempts, or ampullectomy. Post-ERCP pancreatitis was defined as new upper abdominal pain, an increase in pancreatic enzymes to at least 3 times the upper limit of the normal range 24 hours after ERCP, and hospitalization for at least 2 nights.
Each year, about 210,000 Americans are hospitalized with acute pancreatitis, a sometimes-deadly infection, according to the U.S. National Institutes of Health. The main symptom is severe abdominal pain in the upper left or middle regions, and the most common cause of the inflammation is the presence of gallstones, followed by heavy alcohol use.
Lead study author and gastroenterologist, B. Joseph Elmunzer, said, “ERCP is a very important procedure that can provide life-saving interventions for people who need it, although it is considered the most invasive of all the endoscopic procedures and it does have risks associated with it.” In post-ERCP pancreatitis, the pancreas suddenly swells. Experts say this complication incurs approximately $150 million annually in health care costs.
The study found that patients who were given anti-inflammatory indomethacin rectally after their ERCP procedure were dramatically less likely to have to be hospitalized with pancreatitis. One dose of indomethacin costs under $5. The researchers believe indomethacin, an NSAID (non-steroid anti-inflammatory drug), inhibits an inflammatory response by the pancreas; a complication risk after ERCP. “…it remains unclear whether NSAIDs provide incremental benefit over temporary pancreatic stents, the only proven prophylactic intervention for post-ERCP pancreatitis,” Dr. Elmunzer and colleagues write.
Co-author and gastroenterologist Evan L. Fogel, said, “Our findings showed that one dose of indomethacin given immediately after ERCP significantly reduced the incidence of post-ERCP pancreatitis in patients at elevated risk for this complication. We found that prophylactic indomethacin decreased the severity of post-ERCP pancreatitis and was associated with shorter hospital stays.”
Elmunzer said, “The results of the study were very impressive. We found that indomethacin was highly protective. The risk of post-ERCP pancreatitis is in the range of 5 percent, however there are patients who are at higher risk, and without any form of prevention can have up to a 25 percent chance of developing this complication.”
“These recent finding have great clinical relevance,” said Ulrich Christian Bang, from the Department of Gastroenterology at Hvidovre Hospital in Denmark, who was not involved in the work. “In light of the potential severe morbidity related to post-ERCP acute pancreatitis, the benefit of this easily applied prophylactic measure should be interesting news for all clinicians performing ERCPs,” Dr. Bang told Medscape Medical News.
According to Dr. Bang, these findings together with earlier supportive results indicate that NSAIDs administered either orally or rectally are effective. “In light of the minimal side effects associated with 1-dose NSAID (especially no increased prevalence of [gastrointestinal] bleeding), this approach may be valid for immediate introduction into clinical practice,” he said. Dr. Bang added that a difficult task before ERCP is to appropriately identify high-risk patients, and that further studies on certain subgroups are needed. “Nonetheless, indomethacin seems to be the most promising approach to reduce the incidence of post-ERCP for the time being.”
Dr. David Bernstein, chief of the division of gastroenterology at North Shore University Hospital in Manhasset, N.Y., said the drug may significantly reduce the number of costly hospitalizations needed by patients undergoing ERCPs, which typically are done on an outpatient basis. “The study is really straightforward and impressive and surprising,” Bernstein said. “It's a very important finding.”
Elmunzer noted that indomethacin, because of its nominal cost, is “proof of principle” that health care innovations don't have to come with a steep price tag. “Because of how expensive health care is becoming, it's imperative that researchers start looking at innovative, low-cost ways to improve health,” he said. “This is a perfect example.”