Minor papilla sphincterotomy not better than sham in preventing acute pancreatitis

Presented by

Dr Gregory Coté, Oregon Health and Science University, OR, USA

Conference

DDW 2025

Trial

SHARP

Doi
https://doi.org/10.55788/c912679c

Results of the SHARP trial showed that minor papilla sphincterotomy does not reduce the risk for acute pancreatitis or related conditions such as chronic pancreatitis or exocrine pancreatic insufficiency in patients with acute recurrent pancreatitis and pancreas divisum.

“Pancreas divisum is a common anatomic variant that has been associated with acute recurrent pancreatitis,” said Dr Gregory Coté (Oregon Health and Science University, OR, USA) [1]. “Some evidence suggests that endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy improves acute pancreatitis in more than 50% of the patients.” The SHARP trial (NCT03609944) is a sham-controlled, single-blind, multicentre, randomised trial assessing ERCP with minor papilla sphincterotomy. To be eligible for enrolment, patients needed a history of at least 2 documented episodes of idiopathic acute pancreatitis and confirmed pancreas divisum. The 148 participants were randomised 1:1 to a sham procedure or to ERCP and minor papilla sphincterotomy with placement of a prophylactic pancreatic duct stent. The primary endpoint was the development of acute pancreatitis.

After a median of 33.5 months of follow-up, 34.7% of the participants in the active treatment arm experienced acute pancreatitis, compared with 43.8% of the participants in the sham arm (aHR 0.83; 95% CI 0.49–1.41), not representing a significant difference between the study arms. There was also no difference regarding the occurrence of chronic pancreatitis, diabetes mellitus, or exocrine pancreatic insufficiency.

“Minor papilla sphincterotomy did not reduce the risk for acute pancreatitis or associated sequela in patients with acute recurrent pancreatitis and pancreas divisum,” decided Dr Coté.

Coté GA, 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 987a, Digestive Disease Week 2025, 3–6 May 2025, San Diego, USA.

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