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Recruiting

NCT Number: NCT05733130

Italian Registry Chronic Pancreatitis

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

Recruiting

Interested in participating?

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease Progression

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriele Capurso, PhD

CONTACT

[email protected]

00390226436548

Sponsors and collaborators

Lead sponsor

Associazione Italiana per lo Studio del Pancreas

Other

Registry information

Official study title

Registro Italiano Pancreatite Cronica

Acronym: ITARECIPE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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