Clinical Trial of ERCP and Minor Papillotomy for Recurrent Pancreatitis in Pancreas Divisum

Article Impact Level: HIGH
Data Quality: STRONG
Summary of  JAMA, https://doi.org/10.1001/jama.2025.23988 
Dr. Gregory A. Coté  et al.

Points

A multicenter clinical trial demonstrated that performing a minor papillotomy via ERCP does not significantly reduce the recurrence of acute pancreatitis in adults with the congenital defect pancreas divisum.
Statistical analysis showed that thirty-five percent of patients receiving the endoscopic procedure experienced subsequent pancreatitis attacks compared to forty-four percent of those who underwent a sham placebo intervention.
The research indicated that the invasive procedure carried substantial risks as fifteen percent of the treatment group developed acute pancreatitis within thirty days compared to only eight percent of controls.
These findings suggest that the long-held belief in improving pancreatic drainage through minor papilla incisions is not supported by rigorous evidence even though the practice is currently widespread in gastroenterology.
Clinicians are encouraged to reconsider recommending this endoscopic intervention for recurrent pancreatitis and to prioritize the development of safer pharmacological options for patients suffering from these painful inflammatory episodes.

Summary

This multicenter randomized clinical trial evaluated the efficacy of endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy in reducing recurrent acute pancreatitis episodes among adults with pancreas divisum. While pancreas divisum affects 5%–10% of the population and is often implicated as an obstructive cause of inflammation, the effectiveness of surgical drainage via the minor papilla remained unproven. The study enrolled 148 adults with unexplained recurrent attacks across 21 medical centers, utilizing a sham-controlled design to account for the placebo effect of endoscopic intervention.

The primary endpoint was the recurrence of acute pancreatitis over a three-year follow-up period. Results indicated that 35% of the ERCP group experienced a recurrent episode compared to 44% in the sham-procedure group. This difference was determined to be statistically insignificant, with no specific patient subgroup demonstrating a clear benefit from the intervention. These findings challenge the traditional belief that increasing drainage through an internal incision of the minor papilla effectively mitigates the inflammatory stressors associated with this congenital duct defect.

Safety data further complicated the clinical profile of the procedure, as ERCP was associated with a higher rate of immediate complications. Within 30 days of the intervention, 15% of the ERCP cohort developed post-procedure pancreatitis, nearly double the 8% incidence rate observed in the sham group. Given the lack of therapeutic efficacy and the increased risk of procedural harm, the study suggests a critical need to transition away from minor papillotomy as a standard of care for pancreas divisum, shifting focus toward future pharmacological alternatives.

Link to the article: https://jamanetwork.com/journals/jama/article-abstract/2843866

References

Coté, G. A., Durkalski-Mauldin, V., Fogel, E. L., Moffatt, D. C., Wang, A. Y., Lara, L. F., Tarnasky, P. R., Buxbaum, J. L., Dai, S.-C., Jonnalagadda, S., Willingham, F. F., Ross, A., Keswani, R. N., Inamdar, S., Kothari, T. H., Gardner, T. B., Jamidar, P. A., Gaddam, S., Pleskow, D. K., … Torrance, R. (2026). Minor papillotomy for treatment of idiopathic acute pancreatitis with pancreas divisum: A randomized clinical trial. JAMA, 335(8), 682. https://doi.org/10.1001/jama.2025.23988