Serious complication of gastrointestinal procedure can often be avoided with single dose medication

A study in the current issue of the New England Journal of Medicine shows a serious complication of ERCP, a procedure commonly used to diagnose and treat problems of the bile and pancreatic ducts, may be eliminated with a single dose medication.

The finding is significant in helping patients avoid a condition known as post-ERCP pancreatitis, a disabling complication that affects up to 1 in 4 high-risk patients who undergo the gastrointestinal procedure.

Despite decades of research, this clinical trial is the first to clearly demonstrate effective prevention of post-ERCP pancreatitis.

The trial ended early after an interim analysis showed clear safety and benefit for the first 600 patients enrolled. The findings are already changing clinical practice.

"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 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 University of Michigan Health System.

Post-ERCP pancreatitis is a sudden swelling and inflammation of the pancreas that leads to 300,000 hospitalizations a year and costs an estimated $150 million to treat.

This video is not supported by your browser at this time.
The procedure was a success, but afterward 24-year-old Jessica Calcagno experienced stomach pain that she says was so unbearable she went to the emergency room. A study led by University of Michigan physicians shows a single dose of an anti-inflammatory medication can help patients avoid post-ERCP pancreatitis, a common and painful complication of a procedure to diagnose digestive health problems. Credit: University of Michigan Health System

According to the study, hospitalizations for post-ERCP pancreatitis were dramatically reduced by administering a single dose of , an that costs less than $5.

The drug is part of a category of non-steroid that's believed to inhibit an by the pancreas that can occur after endoscopic retrograde cholangiopancreatography, or ERCP.

ERCP combines a lighted scope inserted through the mouth and X-ray pictures to examine the tubes draining the liver, gallbladder and pancreas.

In the study, only 9.2 percent of patients who took indomethacin developed post-ERCP pancreatitis compared to 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."

Some patients have the GI procedure repeated as doctors examine the bile duct and pancreatic duct for growths, stones, open a narrowed duct or to seal leaks after surgery.

Funded by grants from the National Institutes of Health, the trial was conducted February 2009 to July 2011 at the U-M Health System, Indiana University, University of Kentucky and Case Western Reserve University.

The study is the first executed by the United States Cooperative for Outcomes Research in Endoscopy, which provides an open platform for gastrointestinal programs to conduct large-scale patient studies.

Patients like Jessica Calcagno, 24, are benefiting from the research. During an ECRP procedure doctors found and removed a growth, but afterwards Calcagno experienced severe stomach pain that she says was so unbearable she sought help at an emergency room.

She was diagnosed with post- ERCP pancreatitis and hospitalized for five days. Before 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 comfort knowing that I can leave after the procedure and not develop pancreatitis."

Given the magnitude of the problem, over the years researchers have studied more than 35 drugs to prevent post-ECRP pancreatitis, with uncertain conclusions.

"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," Elmunzer says.

"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."

Related Stories

A case of post-gastrectomy acute pancreatitis

Oct 16, 2009

A clinical research team from Taiwan reported a case of asymptomatic pancreatic divisum who underwent palliative subtotal gastrectomy for an advanced gastric cancer with liver metastasis. They concluded for patients with ...

Recommended for you

Liberia holds Senate vote amid Ebola fears

1 hour ago

Health workers manned polling stations across Liberia on Saturday as voters cast their ballots in a twice-delayed Senate vote that has been criticized for its potential to spread the deadly Ebola disease.

Evidence-based recs issued for systemic care in psoriasis

21 hours ago

(HealthDay)—For appropriately selected patients with psoriasis, combining biologics with other systemic treatments, including phototherapy, oral medications, or other biologic, may result in greater efficacy ...

Bacteria in caramel apples kills at least four in US

22 hours ago

A listeria outbreak believed to originate from commercially packaged caramel apples has killed at least four people in the United States and sickened 28 people since November, officials said Friday.

Steroid-based treatment may answer needs of pediatric EoE patients

22 hours ago

A new formulation of oral budesonide suspension, a steroid-based treatment, is safe and effective in treating pediatric patients with eosinophilic esophagitis (EoE), according to a new study in Clinical Gastroenterology and Hepatology, the official clinical practice journal ...

Discovery of genes that predispose a severe form of COPD

Dec 19, 2014

A study by Ramcés Falfán-Valencia, researcher at the National Institute of Respiratory Diseases (INER), found that the mestizo Mexican population has a number of variations in certain genes that predispose ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.