Data_Sheet_1_PrescrAIP: A Pan-European Study on Current Treatment Regimens of Auto-Immune Pancreatitis.PDF

Introduction: Treatment of autoimmune pancreatitis (AIP) is based solely on consensus and has yet to become standardized. Consequently, therapeutic regimens vary greatly between countries and centers, and largely depend on the experience of the physician. At this moment, the optimal regimen for inducing disease remission and preventing relapse is unknown.
Objectives: The primary objective of this study is to describe current treatment regimens used in Europe, and to compare their effectiveness in inducing remission and preventing and treating relapse. The secondary objectives are: to identify risk factors for relapse; to assess the diagnostic accuracy of the Unified-AIP criteria; to assess the performance of the M-ANNHEIM score for predicting relapse; and to assess long-term outcomes including pancreatic exocrine insufficiency and pancreatic cancer.
Methods: This is an international, retrospective, observational cohort study, performed in over 40 centers from 16 European countries. Eligible are all patients diagnosed with AIP from 2005 onwards, regardless of the used diagnostic criteria. Data on study subjects will be retrieved from the hospital's electronic medical records and registered with a standardized, web-based, electronic case report form (eCRF). To compare the effectiveness of treatment regimens in inducing remission, preventing relapse, and treating relapse, subjects will be stratified in groups based on: type of therapy; initial therapy dose; cumulative therapy dose; therapy tapering speed and duration; and having received maintenance therapy or not.
Ethics and Dissemination: Ethical and/or institutional review board approvals are obtained by all participating centers according to local regulations. The study complies with the General Data Protection Regulation (GDPR). All manuscripts resulting from the study will be submitted to peer-reviewed journals.
Conclusion: This is the first pan-European retrospective registry for AIP. It will produce the first large-scale data on treatment of European patients with AIP, providing answers on the use and effectiveness of treatment regimens. In the future, this collaboration may provide a network for continuation into a prospective European registry.

引言：自身免疫性胰腺炎（Autoimmune Pancreatitis, AIP）的治疗目前仅基于专家共识，尚未形成标准化方案。因此，不同国家乃至不同医疗中心间的治疗方案差异极大，且在很大程度上取决于接诊医师的临床经验。截至目前，诱导疾病缓解并预防复发的最优治疗方案仍未明确。

研究目标：本研究的主要目的是梳理欧洲目前临床使用的AIP治疗方案，并对比不同方案在诱导缓解、预防及治疗复发方面的疗效。次要研究目标包括：明确复发的危险因素；评估统一AIP诊断标准（Unified-AIP criteria）的诊断准确性；评估M-ANNHEIM评分预测复发的效能；以及评估长期预后结局，包括胰腺外分泌功能不全与胰腺癌发生风险。

研究方法：本研究为一项国际性回顾性观察队列研究，共纳入16个欧洲国家的40余家医疗中心参与。研究纳入2005年及之后确诊为AIP的所有患者，不受其所采用的诊断标准限制。研究对象的相关数据将从医院电子病历中提取，并通过标准化的网络电子病例报告表（electronic case report form, eCRF）进行登记。为对比不同治疗方案在诱导缓解、预防复发及治疗复发中的疗效，研究将按照以下维度对受试者进行分组：治疗类型、初始治疗剂量、累计治疗剂量、治疗减量速度与疗程，以及是否接受维持治疗。

伦理与成果发布：所有参与中心均已按照当地法规获得伦理委员会及/或机构审查委员会的批准。本研究符合《通用数据保护条例》（General Data Protection Regulation, GDPR）。本研究产生的所有学术论文均将提交至同行评议期刊发表。

结论：本研究是首个覆盖全欧洲的AIP回顾性注册研究。本研究将首次提供欧洲AIP患者治疗的大规模临床数据，为明确治疗方案的应用场景与疗效提供依据。未来，本研究的合作网络可为后续建立前瞻性欧洲AIP注册研究奠定基础。