NCT05733130

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2022Dec 2027

Study Start

First participant enrolled

October 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

5.2 years

First QC Date

February 8, 2023

Last Update Submit

July 10, 2024

Conditions

Keywords

chronic pancreatitissurveillance chronic pancreatitischronic pancreatitis diagnosischronic pancreatitis therapy

Outcome Measures

Primary Outcomes (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.

    5 years

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (8)

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriele Capurso, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

October 10, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations