Italian Registry Chronic Pancreatitis (ITARECIPE)

Associazione Italiana per lo Studio del Pancreas

Status: Enrolling

Conditions: Chronic Pancreatitis

Study type: Observational

Funder types: Other

Identifiers

NCT05733130

ITARECIPE

Details and patient eligibility

About

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

Full 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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.