Italian Registry Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

— ITARECIPE  

Official title:

Registro Italiano Pancreatite Cronica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733130
• Other study ID #: ITARECIPE
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Associazione Italiana per lo Studio del Pancreas
• Contact: Gabriele Capurso, PhD
• Phone: 00390226436548
• Email: capurso.gabriele[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Italiana per lo Studio del Pancreas

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. Gastroente — View Citation

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 adheren — View Citation

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 ar — View Citation

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. — View Citation

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 — View Citation

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; — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years