According to an article in the current issue of the New England Journal of Medicine, one single dose medication may eliminate serious complications of ERCP, a procedure typically applied to diagnose and treat problems of the bile and pancreatic ducts.
This discovery is important, as it benefits patients in avoiding post-ERCP pancreatitis, a disabling complication, which affects up to 1 in 4 high-risk patients who have a gastrointestinal procedure.
Scientists have researched for decades to find an effective way to prevent post-ERCP pancreatitis and this is the first clinical trial that has been able to provide evidence of achieving this goal. The trial ended ahead of schedule, after an interim evaluation confirmed clear safety and benefits for the first 600 patients, and the results are already altering clinical practice.
Leading researcher B. Joseph Elmunzer, M.D., an assistant professor of internal medicine at the University of Michigan Health System explained:
“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.”
Each year, approximately $150 million are spent to treat post-ERCP pancreatitis, a sudden swelling and inflammation of the pancreas. The study reveals that a single dose of indomethacin, an anti-inflammatory medicine costing less than $5, given to patients meant that hospitalizations for post-ERCP pancreatitis were drastically reduced.
Indomethacin belongs to a group of non-steroid anti-inflammatory drugs that is believed to suppress the pancreas’ inflammatory responses that can occur after ERCP (endoscopic retrograde cholangiopancreatography).
The ERCP procedure is a combination of a lighted scope inserted through the mouth and X-ray pictures in order to examine the tubes that drain the gallbladder, liver and pancreas. The study demonstrated that only 9.2% of patients who took indomethacin developed post-ERCP pancreatitis, in comparison with 16.9% of patients who took placebo, which is a decreased risk of 46%.
The trial was conducted between February 2009 and July 2011 at Case Western Reserve University, Indiana University, the U-M Health System, as well as the University of Kentucky, and is the first study by the United States Cooperative for Outcomes Research in Endoscopy, which offers gastrointestinal programs for performing large-scale patient studies on an open platform.
Elmunzer comments:
“The results of the study were very impressive. We found that indomethacin was highly protective.” Some patients require a repeat GI procedure to allow doctors to examine the bile duct and pancreatic duct for growths, stones, an open a narrowed duct or to seal leaks after surgery.
Jessica Calcagno, 24, is one of the patients who benefited from the research. Doctors discovered and removed a growth during an ERCP procedure, however, Calcagno experienced severe stomach pain after the procedure, which she described as unbearable, so she sought help at an emergency room.
The diagnosis was post- ERCP pancreatitis, and Calcagno was hospitalized for five days. She was given indomethacin at her next ERCP at the U-M’s Division of Gastroenterology, and says:
”Following the procedure, I went home and felt fine. I was a little sore, but that’s standard so it was great. I have many more ERCP procedures to go through in my life. I feel comfort knowing that I can leave after the procedure and not develop pancreatitis.”
Researchers have examined over 35 drugs to prevent post-ERCP, as it is a very common problem, yet all drugs led to uncertain conclusions.
Elmunzer concludes:
“Health care costs in the United States are soaring, so it’s important for the scientific community, even individual practitioners, to find innovative, low-cost ways to improve health. I think indomethacin is a perfect example of a widely available, inexpensive, easily administered drug that does exactly that – improves clinical outcomes at extremely low-cost.”
Written By Petra Rattue