Italian Chronic Pancreatitis Registry (ITARECIPE): protocol for a nationwide cohort study.

Abstract

Introduction: Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas leading to permanent damage, resulting in both exocrine and endocrine insufficiency. Understanding the management of patients with CP and their outcomes is critical for improving patient care. CP is relatively rare in Italy and is characterised by various aetiologies and clinical progression requiring personalised treatment options. This registry (ITARECIPE) aims to prospectively collect and analyse data on patients with newly diagnosed CP to gain insights into its epidemiology, presentation, disease progression, and treatment outcomes.

Methods and analysis: This is a multicentre, observational, non-interventional incident cohort study supported by the Italian Association for the Study of the Pancreas and endorsed by relevant Italian gastroenterological societies. ITARECIPE is the first registry in Italy focusing on newly diagnosed CP patients, leading to a comprehensive understanding of disease onset and progression. The study plans to enrol ≥300 patients annually over a minimum of 5 years. Data are recorded in a pseudo-anonymous electronic Case Report Form (eCRF) at baseline and follow-up visits, covering patient demographics, comorbidities, chronic medications, CP aetiology, pancreatic function (exocrine and endocrine), pain, complications, imaging, laboratory tests and treatments. It will track epidemiology, clinical history and treatment outcomes, potentially improving adherence to best practices and informing health policy decisions. The ITARECIPE registry will contribute significantly to the understanding of CP by providing detailed epidemiological, clinical and examinations data into disease management, which could help the development of future clinical practice and guidelines.

Ethics and dissemination: The study was approved by the Ethics Committee (EC) of the promoter centre (San Raffaele Hospital, Milan, Italy; approval code 178/2022) and subsequently by the EC of each participating centre. All patients will be included after signing written informed consent and will be recorded in a pseudo-anonymous manner in a specific eCRF, in accordance with international principles and recommendations for observational studies. The ongoing results may be presented at national or international conferences and will be reported in peer-reviewed publications.

Trial registration number: NCT05733130.