Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2022-10-10
2027-12-31
Brief Summary
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Detailed Description
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Patients need to be treated by different specialists, but almost always the gastroenterologist is central in diagnosis and treatment.
The study will be the first National Registry, prospective and will collect data on the history of the disease and its outcomes.
Data will be collected through an electronic data collection form (e-CRF) that the Sponsor (AISP) will make available to the Participating Centres.
Patients enrolled will be both new diagnoses or follow-up visits of patients with a diagnosis already made no more than 1 year before the signing of informed consent for the study in question: only data on the diagnosis and follow-up visits prior to the signing of the informed consent will be collected retrospectively (no more than one year).
Data from patients visited in the Centres included in the study will be collected prospectively.
In addition to the first visits, data will also be collected on follow-up visits that are scheduled according to the clinical need of each patient, which differ according to the stage of the disease
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis "definite" or "probable" according to the "M-ANNHEIM" criteria;
* First evidence of diagnosis within 12 months of enrolment.
Exclusion Criteria
* History of known disease with certainty for \> 12 months.
12 Years
ALL
No
Sponsors
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Associazione Italiana per lo Studio del Pancreas
OTHER
Responsible Party
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Locations
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IRCCS Ospedale San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Olesen SS, Nojgaard C, Poulsen JL, Haas SL, Vujasinovic M, Lohr M, Lindkvist B, Bexander L, Gulbinas A, Kalaitzakis E, Ebrahim M, Erchinger F, Engjom T, Roug S, Novovic S, Hauge T, Waage A, Laukkarinen J, Parhiala M, Pukitis A, Ozola-Zalite I, Drewes AM; Scandinavian Baltic Pancreatic Club. Chronic Pancreatitis Is Characterized by Distinct Complication Clusters That Associate With Etiological Risk Factors. Am J Gastroenterol. 2019 Apr;114(4):656-664. doi: 10.14309/ajg.0000000000000147.
Engjom T, Nordaas IK, Tjora E, Dimcevski G, Haldorsen IS, Olesen SS, Drewes AM, Zviniene K, Barauskas G, Riis Jespersen HS, Jensen N, Borch A, Nojgaard C, Novovic S, Kardasheva SS, Okhlobystin A, Hauge T, Waage A, Frokjaer JB. Aetiological risk factors are associated with distinct imaging findings in patients with chronic pancreatitis: A study of 959 cases from the Scandinavian Baltic Pancreatic Club (SBPC) imaging database. Pancreatology. 2021 Jun;21(4):688-697. doi: 10.1016/j.pan.2021.02.023. Epub 2021 Mar 3.
Lohr JM, Dominguez-Munoz E, Rosendahl J, Besselink M, Mayerle J, Lerch MM, Haas S, Akisik F, Kartalis N, Iglesias-Garcia J, Keller J, Boermeester M, Werner J, Dumonceau JM, Fockens P, Drewes A, Ceyhan G, Lindkvist B, Drenth J, Ewald N, Hardt P, de Madaria E, Witt H, Schneider A, Manfredi R, Brondum FJ, Rudolf S, Bollen T, Bruno M; HaPanEU/UEG Working Group. United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU). United European Gastroenterol J. 2017 Mar;5(2):153-199. doi: 10.1177/2050640616684695. Epub 2017 Jan 16.
Vege SS, Chari ST. Chronic Pancreatitis. N Engl J Med. 2022 Mar 3;386(9):869-878. doi: 10.1056/NEJMcp1809396. No abstract available.
de Rijk FE, Kempeneers MA, Bruno MJ, Besselink MG, van Goor H, Boermeester MA, van Geenen EJ, van Hooft JE, van Santvoort HC, Verdonk RC; Dutch Pancreatitis Study Group. Suboptimal care for chronic pancreatitis patients revealed by moderate to low adherence to the United European Gastroenterology evidence-based guidelines (HaPanEU): A Netherlands nationwide analysis. United European Gastroenterol J. 2020 Aug;8(7):764-774. doi: 10.1177/2050640620937610. Epub 2020 Jun 26.
Gardner TB, Adler DG, Forsmark CE, Sauer BG, Taylor JR, Whitcomb DC. ACG Clinical Guideline: Chronic Pancreatitis. Am J Gastroenterol. 2020 Mar;115(3):322-339. doi: 10.14309/ajg.0000000000000535.
Beyer G, Mahajan UM, Budde C, Bulla TJ, Kohlmann T, Kuhlmann L, Schutte K, Aghdassi AA, Weber E, Weiss FU, Drewes AM, Olesen SS, Lerch MM, Mayerle J. Development and Validation of a Chronic Pancreatitis Prognosis Score in 2 Independent Cohorts. Gastroenterology. 2017 Dec;153(6):1544-1554.e2. doi: 10.1053/j.gastro.2017.08.073. Epub 2017 Sep 14.
Rizzo GEM, Apadula L, Piciucchi M, Stigliano S, Belfiori G, de Pretis N, Gabbrielli A, Barresi L, Frulloni L, Falconi M, Carrara S, Fabbri C, Capurso G; ITARECIPE study group. Italian Chronic Pancreatitis Registry (ITARECIPE): protocol for a nationwide cohort study. BMJ Open Gastroenterol. 2025 Apr 22;12(1):e001747. doi: 10.1136/bmjgast-2025-001747.
Other Identifiers
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ITARECIPE
Identifier Type: -
Identifier Source: org_study_id
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