CAPER Acute Pancreatitis Registry

Webinar meeting Saturday February 28th

Webinar Agenda

Welcome

 Welcome Georgios Papachristou (University of Pittsburgh)  Introduction to CAPER David Whitcomb (University of Pittsburgh)  Review of Acute Pancreatitis Registry  Previous experience with collaborative studies Vikesh Singh (Johns Hopkins University)  Discussion among participants

Introduction to CAPER

Acute Pancreatitis Registry “An international multicenter collaboration”

Acute Pancreatitis Registry • Design, Objectives • Observational prospective study • Development of a large cohort of pts to study: o Severity Risks (Age, Gender, Obesity) o Biomarkers & Scores (BUN, Hct, SIRS) o Management (IV Fluids, ICU, Nutritional Support, Interventions) o Severity Classification (RAC, DBC) o Outcomes (OF, PNec, LOS, Mortality)

• Pilot Study • Platform for future collaborations for RCTs and funding

Practical points • Approval by Ethics Committee o Are any centers with active IRB? o This is a minimal risk (non-interventional) study o Data transfer agreement if applicable

• Identification of eligible patients o UPMC: Lipase reports, PB service o Other options: through the ER

• Prospective data collection o Timely recording

• Access and technical aspects of REDCap

• Secure web based application for managing online databases • FDA CFR Part 11 compliance / HIPAA compliance central data repository in University of Pittsburgh Servers • Access: Secure unique access, Data trails

• Data Access Groups • Training for coordinators

• Reviewing data collection, progress

• Data import, export • Data extraction, Analysis

Previous experience

Questioners Demographics • Age/Sex/Race/BMI • Charlson Comorbidity Index • Smoking/Alcohol • Pre-existing DM Medications • NSAIDS use the last 7 days • Statin use

Questioners AP characteristics • Etiology • Number of prior AP episodes • Date and time of pain onset • Date and time of Initial Admission • Transfer status Early prognostic markers and scores • BUN • HCT On admission and 24 hours • CRP • SIRS

Questioners Management • IV Fluids in the first 24hrs • ICU care • Nutritional support • Early intervention within 2 weeks • Delayed drainage/debridement

Questioners Clinical Outcomes • Organ Failure • Pancreatic Necrosis • Symptomatic local complications • Duration of parenteral narcotics • Total hospital LOS • Mortality • Revised Atlanta Classification • Determinant-based classification

Questioners F/u btw 30 and 90 days: • Number of ER visits related to AP since discharge • Number of hospitalizations related to AP since discharge • New onset diabetes • Medications (0=n, 1=insulin, 3=oral antidiabetic drugs) • Pancreatic insufficiency (PI) • Pancreatic enzymes

Step#2 within 2 weeks • Via e-mail: • Confirm interest in participating • Provide feedback on Protocol and Questioners (available on CAPER website) • Assign PI and “research coordinator” • Progress with IRB & Data transfer Agreement • Plan for patient identification & follow-up

Step#3 in 1 month • Follow up Webinar with each center’s PI/Research coordinator participating • Potential date Saturday, April 4th at the same time

Open to discussion