Australian Pancreatic Cyst Registry: protocol for a prospective national clinical quality registry of intraductal papillary mucinous neoplasms.

Abstract

Intraductal papillary mucinous neoplasms (IPMNs) are common pancreatic cystic neoplasms with malignant potential. Current evidence on IPMN management is derived largely from retrospective surgical cohorts that over-represent high-risk cases and provide limited insight into the long-term outcomes of conservatively managed lesions. Australia currently lacks a prospective national dataset to evaluate surveillance pathways, practice patterns, guideline adherence and long-term outcomes in individuals with IPMN. Variation between international guideline recommendations may also contribute to differences in surveillance intensity and thresholds for intervention. The Australian Pancreatic Cyst Registry (APCR) was established to address these evidence gaps. The APCR is a prospective, multicentre clinical quality registry that collects clinical, imaging, management and outcome data for individuals with IPMN across public and private healthcare settings in Australia. Historical information is extracted from existing clinical documentation where available, with prospective data collection continuing during routine follow-up. The registry operates under an opt-out model and aims to enrol up to 10 000 participants over a 5-year recruitment period. Participants are followed through routine clinical care until discharge from surveillance, diagnosis of pancreatic cancer, withdrawal or death. Standardised electronic case report forms capture clinical and imaging variables aligned with risk features described in the 2024 Kyoto guidelines. This analysis will describe participant characteristics, cyst features, management and clinical outcomes, with comparative, time-to-event and multivariable analyses undertaken where appropriate. Guideline adherence and the predictive performance of established risk stratification frameworks will also be evaluated. The study protocol was approved by the Monash Health Human Research Ethics Committee (Project ID: RES-24-0000-634A). Findings will be disseminated through peer-reviewed publications, conference presentations and updates to participating sites.