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.

Keywords: CHRONIC PANCREATITIS; DIAGNOSTIC AND THERAPEUTIC ENDOSCOPY; SURVEILLANCE.

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简介： 慢性胰腺炎（CP）是一种进行性的胰腺炎症性疾病，导致永久性损伤，进而引起外分泌和内分泌功能不全。了解CP患者管理及其预后的关键在于提高患者的护理质量。在意大利，CP相对罕见，并且具有多种病因学特点和临床进展过程，需要个性化的治疗方案。该注册研究（ITARECIPE）旨在前瞻性地收集和分析新诊断为CP的患者数据，以深入了解其流行病学、发病表现、疾病进展及治疗结果。

方法与分析： 这是一项由意大利胰腺研究协会支持，并得到相关意大利胃肠病学会认可的多中心观察性非干预性的首发病例队列研究。ITARECIPE是意大利首个专注于新诊断CP患者的注册项目，旨在全面了解疾病的发生和发展过程。该研究计划每年招募至少300名患者，持续五年或更长时间。数据以伪匿名方式记录在基线和随访访问的电子病例报告表（eCRF）中，涵盖患者的基线特征、伴随疾病情况、慢性药物治疗、CP病因学、胰腺功能（外分泌和内分泌）、疼痛程度、并发症、影像学检查、实验室检验结果及治疗方法。这项研究将跟踪流行病学趋势、临床史及治疗效果，有可能提高对最佳实践的遵守，并为健康政策决策提供信息支持。ITARECIPE注册项目通过提供详细的流行病学、临床和检查数据，有助于深入了解CP管理中的问题，从而帮助未来临床实践指南的发展。

伦理与传播： 该研究得到了发起中心（意大利米兰圣拉斐尔医院；批准代码178/2022）的伦理委员会(EC)批准，并随后得到每个参与中心的EC批准。所有患者在签署书面知情同意书后将被纳入研究，以伪匿名方式记录在一个特定的eCRF中，符合国际观察性研究的原则和建议。正在进行的研究成果可能将在国家或国际会议上展示，并会在同行评审出版物上报道。

试验注册号： NCT05733130。

关键词： 慢性胰腺炎；诊断与治疗内镜检查；监测。