ERCP Sphincterotomy Does Not Reduce Acute Pancreatitis Risk in Pancreas Divisum

New research suggests endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) does not reduce the risk of acute pancreatitis or related sequelae in patients with acute recurrent pancreatitis and pancreas divisum.

Findings from the multicenter, sham-controlled SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial were presented during a late-breaking session at Digestive Disease Week (DDW) 2025 by Gregory Cote, MD, a professor of medicine and head of the division of gastroenterology and hepatology at Oregon Health and Science University, and suggest the procedure does not ameliorate acute pancreatitis risk in this patient population.

“Physicians would report on the safety of the procedure, the technical success of the procedure, and they would observe that anywhere between 20 to 40% of patients would develop another episode of acute pancreatitis… so more than half of patients would do well,” Cote explained to HCPLive. “So it has basically been concluded, until now, that this is a reasonable procedure to offer to patients who have acute pancreatitis, who have [pancreas divisum] and don't have another clear explanation for their acute pancreatitis.”

Citing recent criticisms of this approach, Cote and colleagues conducted a sham-controlled, single blinded with a blinded outcome assessment, multicenter, randomized clinical trial of ERCP with miES in patients with a history of ≥ 2 documented episodes of idiopathic acute pancreatitis, ≥ 1 within 24 months prior to randomization, and pancreas divisum confirmed by magnetic resonance cholangiopancreatography. Patients with other etiologies for acute pancreatitis, main pancreatic duct stricture, or chronic calcific pancreatitis were excluded.

After informed consent, patients were randomly assigned to undergo a diagnostic endoscopic ultrasound (EUS) with sham ERCP, including photodocumentation of minor papilla and placement of a pancreatic duct stent into the duodenal lumen, or EUS with ERCP and miES with placement of a prophylactic pancreatic duct stent. Of note, participants were blinded to their treatment group and a blinded physician evaluated patients >30 days after randomization when acute pancreatitis was suspected.

The primary outcome was development of acute pancreatitis, defined by revised Atlanta Classification as a time-to-event measure. Secondary outcomes included the incidence rate ratio of acute pancreatitis before and after randomization, development of chronic pancreatitis, and pancreas-related adverse events. Participants were followed for ≥ 6 and ≤ 48 months.

From September 2018 to August 2024, 148 patients were randomly assigned to miES (n = 75) or sham ERCP (n = 73). Participants had a median of 3 acute pancreatitis episodes prior to randomization, and the median age at first acute pancreatitis was 51 (12-89 years).

“What we discovered in this study, where we actually hoped to prove once and for all that it would be helpful, was that it in fact is not helpful,” Cote said.

Deep cannulation and miES were achieved in 92% of those randomized to miES and post-ERCP acute pancreatitis occurred in 7.4%. During a median follow-up of 33.5 months, 34.7% patients in the miES arm had an acute pancreatitis event compared with 43.8% in the sham arm (adjusted hazard ratio, 0.83; 95% CI, 0.49-1.41). The incidence rate ratio was 0.230 for miES compared with 0.277 for sham, indicating acute pancreatitis episode frequency after randomization reduced in both study arms.

Investigators did not observe any differences in incident chronic pancreatitis, diabetes mellitus, and exocrine pancreatic insufficiency during follow-up. The occurrence of pancreas-related abdominal pain > 30 days post-randomization or follow-up ERCP 33.3% for miES versus 31.5% for sham participants.

“This is very important for primary care providers, radiologists, and gastroenterologists like myself who do these procedures, and even general surgeons who see patients with acute pancreatitis, because now, when pancreas divisum is discovered on imaging studies, the knee jerk reaction should not be that this patient should be referred, or I should perform, an ERCP with sphincterotomy, as has been offered for many, many years now,” Cote said. “We should take a step back and put it into the context of the whole patient, and at this point, withhold a potentially harmful and what now appears to be a very unhelpful procedure.”

Editors’ note: Cote has relevant disclosures with Olympus.

Reference

1. Cote GA, Durkalski-Mauldin V, Fogel EL, et al. MINOR PAPILLA SPHINCTEROTOMY DOES NOT REDUCE THE RISK OF ACUTE PANCREATITIS IN PATIENTS WITH ACUTE RECURRENT PANCREATITIS AND PANCREAS DIVISUM: THE SHARP TRIAL. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.