Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

Abstract

Background: We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials.

Methods: The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients.

Results: Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results.

Conclusion: APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

Keywords: APPRENTICE; Acute pancreatitis; international multicenter consortium; methodology.

Figure 1

APPRENTICE methodology flowchart

Figure 2

Distribution of patients enrolled across APPRENTICE centers UPMC, University of Pittsburgh Medical Center; MUSC, Medical University of South Carolina; AGH, Apollo Gleneagles Hospital, India; PGIMER, Postgraduate Institute of Medical Education and Research, India; LUHS, Lithuanian University of Health Sciences, Lithuania; UEHB, University Emergency Hospital Bucharest, Romania; AUH, Attikon University Hospital, Greece; UMPIHCN, University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca, Romania; SUR, Sapienza University of Rome, Italy; HNI, Hospital Nacional de Itauguá, Paraguay; HNPAP, Hospital Nacional “Profesor A. Posadas”, Argentina; HGADCA, Hospital General de Agudos “Dr. Cosme Argerich”, Argentina; UANL, Universidad Autónoma de Nueva León, Mexico; INCMNSZ, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico