Rizzo Giacomo Emanuele Maria, Apadula Laura, Piciucchi Matteo, Stigliano Serena, Belfiori Giulio, de Pretis Nicolò, Gabbrielli Armando, Barresi Luca, Frulloni Luca, Falconi Massimo, Carrara Silvia, Fabbri Carlo, Capurso Gabriele
Gastroenterology and Endoscopy Unit, Istituto mediterraneo per i trapianti e terapie ad alta specializzazione, ISMETT- IRCCS, Palermo, Italy.
Pancreato-Biliary Endoscopy and Endosonography Division, Clinical Research Centre, Pancreas Translational and Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy.
BMJ Open Gastroenterol. 2025 Apr 22;12(1):e001747. doi: 10.1136/bmjgast-2025-001747.
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.
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.
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.
NCT05733130.
慢性胰腺炎（CP）是一种胰腺的进行性炎症性疾病，会导致永久性损伤，进而引起外分泌和内分泌功能不全。了解CP患者的管理方法及其治疗结果对于改善患者护理至关重要。CP在意大利相对少见，其病因多样，临床进展需要个性化的治疗方案。该注册研究（ITARECIPE）旨在前瞻性收集和分析新诊断的CP患者的数据，以深入了解其流行病学、临床表现、疾病进展和治疗结果。
这是一项由意大利胰腺研究协会支持、得到意大利相关胃肠病学学会认可的多中心、观察性、非干预性发病队列研究。ITARECIPE是意大利首个专注于新诊断CP患者的注册研究，有助于全面了解疾病的发病和进展情况。该研究计划在至少5年内每年招募≥300名患者。在基线和随访时，数据记录在一个伪匿名电子病例报告表（eCRF）中，涵盖患者人口统计学信息、合并症、慢性用药情况、CP病因、胰腺功能（外分泌和内分泌）、疼痛、并发症、影像学检查、实验室检查和治疗情况。它将追踪流行病学、临床病史和治疗结果，可能会提高对最佳实践的依从性，并为卫生政策决策提供依据。ITARECIPE注册研究将通过提供有关疾病管理的详细流行病学、临床和检查数据，为CP的认识做出重大贡献，这有助于未来临床实践和指南的制定。
该研究已获得发起中心（意大利米兰圣拉斐尔医院；批准代码178/2022）伦理委员会（EC）的批准，随后各参与中心的EC也予以批准。所有患者在签署书面知情同意书后将被纳入研究，并将按照国际观察性研究的原则和建议，以伪匿名方式记录在特定的eCRF中。正在进行的研究结果可能会在国内或国际会议上展示，并将在同行评审的出版物中报告。
NCT05733130。
