Italian Registry Chronic Pancreatitis

NCT ID: NCT05733130

Last Updated: 2024-07-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2027-12-31

Brief Summary

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ITARECIPE is a multicenter national registry designed to study the diagnosis and evolution of Chronic Pancreatitis

Detailed Description

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Chronic pancreatitis (PC) is a relatively rare disease (45/100,000 population) in Italy, with heterogeneous aetiology, clinical history and treatment.

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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Chronic Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \>/= 12 years;
* Diagnosis "definite" or "probable" according to the "M-ANNHEIM" criteria;
* First evidence of diagnosis within 12 months of enrolment.

Exclusion Criteria

* Age \< 12 years;
* History of known disease with certainty for \> 12 months.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associazione Italiana per lo Studio del Pancreas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gabriele Capurso, PhD

Role: CONTACT

00390226436548

Facility Contacts

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Gabriele Capurso, PhD

Role: primary

00390226436548

Laura Apadula, MSN

Role: backup

00390226433979

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.

Reference Type RESULT
PMID: 30741740 (View on PubMed)

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.

Reference Type RESULT
PMID: 33707113 (View on PubMed)

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.

Reference Type RESULT
PMID: 28344786 (View on PubMed)

Vege SS, Chari ST. Chronic Pancreatitis. N Engl J Med. 2022 Mar 3;386(9):869-878. doi: 10.1056/NEJMcp1809396. No abstract available.

Reference Type RESULT
PMID: 35235728 (View on PubMed)

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.

Reference Type RESULT
PMID: 32588790 (View on PubMed)

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.

Reference Type RESULT
PMID: 32022720 (View on PubMed)

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.

Reference Type RESULT
PMID: 28918191 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40262909 (View on PubMed)

Other Identifiers

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ITARECIPE

Identifier Type: -

Identifier Source: org_study_id

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