No Benefit to ERCP With Sphincterotomy in Pancreas Divisum

Medscape

09-05-2025

SAN DIEGO — In treating pancreas divisum, the common use of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy showed no significant benefit over a sham procedure, suggesting that patients can be spared the intervention, which can carry risks of its own.
'This is a topic that has been debated for decades,' said first author Gregory A. Coté, MD, Division Head, professor of medicine, Division of Gastroenterology & Hepatology, Oregon Health & Science University, in Portland, Oregon.
'Many doctors believe the procedure helps and offer it because we have limited options to help our patients, whereas others believe the procedure is harmful and doesn't help,' he explained in a press briefing for the late-breaking study, presented at Digestive Disease Week (DDW) 2025.
The study's findings supported the latter argument.
'Patients who underwent ERCP with sphincterotomy were just as likely as those who did not have this procedure to develop acute pancreatitis again,' Coté reported.
While clinical guidelines currently recommend ERCP as treatment for pancreas divisum, 'these guidelines are likely to change based on this study,' he said.
Pancreas divisum, occurring in about 7%-10% of people, is an anatomic variation that can represent an obstructive risk factor for acute recurrent pancreatitis.
The common use of ERCP with minor papilla endoscopic sphincterotomy to treat the condition is based on prior retrospective studies showing that in patients who did develop acute pancreatitis, up to 70% with the treatment never developed acute pancreatitis again. However, there have been no studies comparing the use of the treatment with a control group.
Coté and colleagues conducted the multicenter SHARP trial, in which 148 patients with pancreas divisum were enrolled between September 2018 and August 2024 and randomized to receive either ERCP with minor papilla endoscopic sphincterotomy (n = 75) or a sham treatment (n = 73).
The patients, who had a median age of 51 years, had a median of 3 acute pancreatitis episodes prior to randomization.
With a median follow-up of 33.5 months (range, 6-48 months), 34.7% of patients in the ERCP arm experienced an acute pancreatitis incident compared with 43.8% in the sham arm, for a hazard ratio of 0.83 after adjusting for duct size and the number of episodes, which was not a statistically significant difference ( P = .27).
A subgroup analysis further showed no indication of a treatment effect based on factors including age, diabetes status, sex, alcohol or tobacco use, or other factors.
'Compared with a sham ERCP group, we found that minor papillotomy did not reduce the risk of acute pancreatitis, incident chronic pancreatitis, endocrine pancreatic insufficiency or diabetes, or pancreas-related pain events,' Coté said.
The findings are particularly important because the treatment itself is associated with some risks, he added.
'Ironically, the problem with this procedure is that it can cause acute pancreatitis in 10%-20% of patients and may instigate other issues later,' such as the development of scarring of the pancreas related to incisions in the procedure.
'No one wants to offer an expensive procedure that has its own risks if it doesn't help,' Coté said.
Based on the findings, 'pancreas divisum anatomy should no longer be considered an indication for ERCP, even for idiopathic acute pancreatitis,' he concluded.