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Chronic PancreatitisITARECIPENCT05733130

Italian Registry Chronic Pancreatitis

An observational study of Chronic Pancreatitis, run by Associazione Italiana per lo Studio del Pancreas at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 12 years and older
Conditions the study is for
Chronic Pancreatitis
How many people
1,500 participants
Where
1 siteItaly
Study dates
10 Oct 2022to 31 Dec 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients with: * a new suspected (both clinical and/or diagnostic evaluation, indicating a suspected diagnosis according to standard criteria) * established diagnosis of Chronic Pancreatitis and willing to provide their clinical and anamnestic information.

Who may be able to join

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

Who cannot join

  • Age < 12 years;
  • History of known disease with certainty for > 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriele Capurso, PhD contact

00390226436548

capurso.gabriele@hsr.it

Italy1 site, 1 recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Gabriele Capurso, PhD, 00390226436548, capurso.gabriele@hsr.it

    Laura Apadula, MSN, 00390226433979, apadula.laura@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: Registro Italiano Pancreatite Cronica

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

Read the detailed description

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

Keywords
chronic pancreatitis, surveillance chronic pancreatitis, chronic pancreatitis diagnosis, chronic pancreatitis therapy
Medical subject headings
Pancreatitis, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Progression

    The collection of data on disease progression in terms of the need for medical, endoscopic or surgical therapy, the risk of pancreatic exo-endocrine failure and the risk of developing pancreatic and extrapancreatic complications and death.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start10 Oct 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733130
Sponsor's protocol ID
ITARECIPE
Acronym
ITARECIPE
Status last verified
Jul 2024
First submitted
8 Feb 2023
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30741740

  • 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.

    PubMed 33707113

  • 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.

    PubMed 28344786

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

    PubMed 35235728

  • 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.

    PubMed 32588790

  • 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.

    PubMed 32022720

  • 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.

    PubMed 28918191

  • 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.

    PubMed 40262909

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pancreatitis, run by Associazione Italiana per lo Studio del Pancreas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriele Capurso, PhD (00390226436548, capurso.gabriele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Progression (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05733130, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.

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