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Autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR): a multicentre, retrospective study protocol

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Title: Autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR): a multicentre, retrospective study protocol
Authors: Cardinal von Widdern, Julian, Knoph, Cecilie Siggaard, Kase, Karri, Regel, Ivonne, Rosendahl, Jonas, Ammer-Hermenau, Christoph, Nikolic, Sara
Source: Cardinal von Widdern, J, Knoph, C S, Kase, K, Regel, I, Rosendahl, J, Ammer-Hermenau, C & Nikolic, S 2025, 'Autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR): a multicentre, retrospective study protocol', BMJ Open, vol. 15, no. 2, e086824. https://doi.org/10.1136/bmjopen-2024-086824
Publication Year: 2025
Collection: Aalborg University (AAU): Publications / Aalborg Universitet: Publikationer
Subject Terms: Autoimmune Diseases/epidemiology, Autoimmune Pancreatitis/epidemiology, Female, Humans, Incidence, Male, Multicenter Studies as Topic, Neoplasms/epidemiology, Pancreatic Neoplasms/epidemiology, Research Design, Retrospective Studies, ONCOLOGY, EPIDEMIOLOGY, Pancreatic disease
Description: Introduction Autoimmune pancreatitis (AIP) mainly manifests in two distinct forms with different clinical, serological and prognostic characteristics. Previous studies indicated a higher risk of malignancy in AIP patients compared with the general population. However, a direct comparison of cancer incidence in AIP patients with controls from the general population has not been conducted yet. Methods and analysis This is an international, multicentre, retrospective study on patients diagnosed with AIP after 2005. Retrospective data regarding demography, AIP characteristics and cancer incidence will be extracted from the medical files of AIP patients. The primary outcome is the standardised incidence ratio of any first invasive cancer after AIP diagnosis compared with the general population. The expected number of cancers in the general population will be determined using the ‘Cancer Incidence in Five Continents Volume XI’ registry. Secondary outcomes are the prevalence of all cancer diagnoses within 12 months prior to AIP diagnosis and AIP features associated with a cancer diagnosis. Ethics and dissemination This study was approved by the ethics committees of the autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR) core group centres (Halle (Saale), Germany; Aalborg, Denmark; Tartu, Estonia; Munich, Germany; Göttingen, Germany; Maribor, Slovenia, with the following reference numbers: 2023–204, 2023–0 29 953, 382 /T-3, 24–0768, 9/7/23, UKC-MB-KME 59/23, respectively). Where required, the study protocol will be reviewed and approved by the ethics committees of participating centres in compliance with local regulations. Data will be stored in an electronic case report form within REDCap. In this context, the AIPPEAR core group will share joint responsibility for the data. All results from this study will be submitted to international, peer-reviewed journals and presented at international conferences. Trial registration number NCT06328101.
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/39956600; info:eu-repo/semantics/altIdentifier/pissn/2044-6055; info:eu-repo/semantics/altIdentifier/eissn/2044-6055
DOI: 10.1136/bmjopen-2024-086824
Availability: https://vbn.aau.dk/da/publications/a5efc86c-44de-4d00-89f1-c27ba7d46d90
https://doi.org/10.1136/bmjopen-2024-086824
https://vbn.aau.dk/ws/files/772227630/von_Widdern_et_al._2025_._Autoimmune_pancreatitis_pancreatic_and_extrapancreatic_cancer_AIPPEAR_-_a_multicentre_retrospective_study_protocol.pdf
https://www.scopus.com/pages/publications/85218140568
Rights: info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc/4.0/
Accession Number: edsbas.4A9DCE4E
Database: BASE
Description
Abstract:Introduction Autoimmune pancreatitis (AIP) mainly manifests in two distinct forms with different clinical, serological and prognostic characteristics. Previous studies indicated a higher risk of malignancy in AIP patients compared with the general population. However, a direct comparison of cancer incidence in AIP patients with controls from the general population has not been conducted yet. Methods and analysis This is an international, multicentre, retrospective study on patients diagnosed with AIP after 2005. Retrospective data regarding demography, AIP characteristics and cancer incidence will be extracted from the medical files of AIP patients. The primary outcome is the standardised incidence ratio of any first invasive cancer after AIP diagnosis compared with the general population. The expected number of cancers in the general population will be determined using the ‘Cancer Incidence in Five Continents Volume XI’ registry. Secondary outcomes are the prevalence of all cancer diagnoses within 12 months prior to AIP diagnosis and AIP features associated with a cancer diagnosis. Ethics and dissemination This study was approved by the ethics committees of the autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR) core group centres (Halle (Saale), Germany; Aalborg, Denmark; Tartu, Estonia; Munich, Germany; Göttingen, Germany; Maribor, Slovenia, with the following reference numbers: 2023–204, 2023–0 29 953, 382 /T-3, 24–0768, 9/7/23, UKC-MB-KME 59/23, respectively). Where required, the study protocol will be reviewed and approved by the ethics committees of participating centres in compliance with local regulations. Data will be stored in an electronic case report form within REDCap. In this context, the AIPPEAR core group will share joint responsibility for the data. All results from this study will be submitted to international, peer-reviewed journals and presented at international conferences. Trial registration number NCT06328101.
DOI:10.1136/bmjopen-2024-086824