# SpHincterotomy for Acute Recurrent Pancreatitis

> **NIH NIH U01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2022 · $1

## Abstract

Project summary
 Acute pancreatitis is among the most common gastrointestinal causes for hospitalization in the U.S.
Roughly one in five patients with acute pancreatitis will have recurrent bouts. Recurrent acute pancreatitis (RAP)
is a strong risk factor for progression to chronic pancreatitis, an irreversible fibroinflammatory disease that greatly
impacts quality of life, and is also a risk factor for pancreatic cancer. Increased intraductal pressure is an
accepted cause for precipitating an episode of acute pancreatitis. Pancreas divisum, seen in 7-10% of the
general population, occurs when the dorsal and ventral pancreatic ducts have incomplete or nonexistent fusion
during early embryologic development. Using this rationale, endoscopists often perform endoscopic retrograde
cholangiopancreatography (ERCP) with minor papilla sphincterotomy (miES) in patients who have idiopathic
RAP (iRAP) and pancreas divisum with a goal to reduce subsequent attack(s). This practice remains highly
controversial, due to major limitations in the available data which are derived almost exclusively from small,
retrospective cohort studies with inconsistent and subjective outcomes. This is one of the highest risk indications
for ERCP, having post-ERCP pancreatitis rates of 10-20%. A full scale, well-designed clinical trial with adequate
follow-up and blinded treatment allocation is clearly needed to empirically evaluate the efficacy of miES in the
setting of iRAP and pancreas divisum, including quantifying the cumulative benefit of this intervention on disease
burden and to study its relationship with its natural history.
 The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a sham-controlled, single blind
with a blinded outcome assessment, randomized trial evaluating the impact of miES on the natural history of
iRAP in patients with pancreas divisum. The primary outcome is reducing the risk of subsequent acute
pancreatitis (time-to-event), with secondary outcome measures being the change in incidence rate of attacks,
patient-centered outcomes, and progression to chronic pancreatitis. By having an adequate sample size to
measure the benefit of ERCP, we will be able to definitively establish the therapeutic role of ERCP in patients
with iRAP and pancreas divisum. A biorepository will be established for future exploratory studies of novel risk
factors for RAP, progression to chronic pancreatitis and its sequelae, and factors associated with response to
miES. Patients fulfilling the entry criteria but refusing enrollment into the randomized trial will be enrolled into an
observational cohort. Irrespective of the outcome, this study will have an immediate impact on patient care by
confirming or refuting the therapeutic role of ERCP in patients with iRAP and pancreas divisum.
!

## Key facts

- **NIH application ID:** 10480901
- **Project number:** 5U01DK116743-05
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Gregory A Cote
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1
- **Award type:** 5
- **Project period:** 2021-09-03 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480901

## Citation

> US National Institutes of Health, RePORTER application 10480901, SpHincterotomy for Acute Recurrent Pancreatitis (5U01DK116743-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10480901. Licensed CC0.

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