Only 9.2 percent of patients who took indomethacin developed post-ERCP pancreatitis.
NSAID prevents post-ERCP pancreatitis
issue 16 | summer 2012
The procedure was a success, but after ERCP, 24-year-old Jessica Calcagno experienced abdominal pain that she says was so unbearable she went to the emergency room.
A clinical trial led by gastroenterologists at the University of Michigan shows, for the first time, an effective way for patients like Jessica to avoid post-endoscopic retrograde cholangiopancreatography pancreatitis, a common and painful complication of the GI procedure used to diagnose and treat problems of the bile and pancreatic ducts.
The finding is significant in helping the one in four high-risk patients who develop post-ERCP pancreatitis.
"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," says lead study author and gastroenterologist B. Joseph Elmunzer, M.D., assistant professor of internal medicine at the U-M Medical School.
According to the study, published in the New England Journal of Medicine, hospitalizations for post-ERCP pancreatitis were dramatically reduced by administering a single dose of the non-steroid anti-inflammatory drug indomethacin. Indomethacin is believed to inhibit an inflammatory response by the pancreas that can occur after ERCP.
The primary focus of the research was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.
But according to the study, only 9.2 percent of patients who took indomethacin developed post-ERCP pancreatitis, compared with 16.9 percent of those who took a placebo -- a 46 percent drop in relative risk.
"The results of the study were very impressive," Elmunzer says. "We found that indomethacin was highly protective."
The trial ended early after an interim analysis showed clear safety and benefit for the first 600 patients enrolled. The trial is already changing clinical practice.
Calcagno suffered post-ERCP pancreatitis after doctors performed ERCP to find and remove a growth. She was hospitalized for five days because of the complication. At her next ECRP at the U-M's Division of Gastroenterology, she was given indomethacin.
"Following the procedure, I went home and felt fine. I was a little sore, but that's standard so it was great," she says. "I have many more ERCP procedures to go through in my life. I feel comforted knowing that I can leave after the procedure and not develop pancreatitis."