For decades, many doctors believed that a certain endoscopic procedure could help prevent repeated episodes of pancreatitis in people with a specific birth defect of the pancreas. But now, a large new clinical trial says otherwise.
The study, published in JAMA, shows that a procedure called ERCP with minor papillotomy does not actually reduce the risk of future pancreatitis attacks in adults with a condition known as pancreas divisum.
Pancreas divisum is an anatomic condition where the pancreas drains its digestive juices through a smaller opening in the intestine than usual. This happens in about 5% to 10% of people, but only a few develop problems like recurrent acute pancreatitis—a painful inflammation of the pancreas.
For a long time, many doctors thought that making a small internal cut during an ERCP procedure could help improve the flow of digestive juice and stop further inflammation.
That changed with this new study led by researchers from 21 medical centers across the United States and Canada. They looked at 148 adults with pancreas divisum and repeated pancreatitis episodes that couldn’t be explained by other conditions.
Some of these patients received the real treatment—an ERCP procedure with a minor papillotomy. Others received a sham procedure, which mimicked the real one but did not include the actual treatment.
After following the patients for nearly three years, the researchers found that the treatment did not make a meaningful difference. About 35% of those who had the real ERCP treatment experienced another episode of pancreatitis. For those who got the sham treatment, the rate was 44%.
This small difference was not statistically significant, meaning it could have happened by chance. The researchers also looked to see if any smaller groups of patients might have benefited more from the procedure.
The results also raised concerns about safety. Within the first 30 days, 15% of patients who received the ERCP procedure developed pancreatitis, compared to 8% of those in the placebo group. These findings suggest the procedure may not only be ineffective—it could also pose additional risks.
Dr. Rajesh Keswani, one of the study’s co-authors, said these findings are likely to influence how doctors treat patients with pancreas divisum moving forward. For a long time, ERCP with minor papillotomy has been a go-to option for trying to prevent repeated pancreas attacks. Now, the data suggest it may be time to reconsider this approach.
“This is surprising and challenges what many of us were taught and practiced,” said Keswani. He emphasized that while it’s important to help patients suffering from repeated attacks, this study shows that ERCP may not be the answer. Instead, doctors may need to look for other options, possibly focusing on medications in the future.
The study serves as a reminder of how important it is to test medical procedures rigorously, even those that have been used for years. Without strong evidence, practices that seem helpful might not only be ineffective—they could also cause harm.
The researchers hope these findings will push the medical field to develop safer, more effective ways to help patients with pancreas divisum and repeated pancreatitis.
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