ITARECIPE: Italian Registry Chronic Pancreatitis
Study Details
Study Description
Brief Summary
ITARECIPE is a multicenter national registry designed to study the diagnosis and evolution of Chronic Pancreatitis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Outcome Measures
Primary Outcome Measures
- Disease Progression [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >/= 12 years;
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Diagnosis "definite" or "probable" according to the "M-ANNHEIM" criteria;
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First evidence of diagnosis within 12 months of enrolment.
Exclusion Criteria:
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Age < 12 years;
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History of known disease with certainty for > 12 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale San Raffaele | Milan | Italy | 20132 |
Sponsors and Collaborators
- Associazione Italiana per lo Studio del Pancreas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITARECIPE