Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Abstract
The Pancreatic Endotherapy for Refractory Chronic PancreaTitis (PERCePT) trial is a single center, pilot, sham controlled trial of pancreatic endoscopy therapy for painful chronic pancreatitis. During year 1, the study protocol was finalized and approved by the Human Subjects Research Protection Office at the Medical University of South Carolina. A Data and Safety Monitoring Board was established and convened its first meeting. The Statistical Data and Coordinating Center finalized the case report forms and electronic database. The Electronic Momentary Assessment tool was developed; this will be used to monitor pain and other metrics throughout the clinical trial. Screening for eligible subjects commenced in June 2020; the ongoing COVID-19 pandemic presents an added challenge with coordination of screening and baseline visits, since most non-procedure clinical care has shifted temporarily to a virtual format. Efforts are now focused on screening and recruitment for the end of year 1 and beginning of year 2.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2020
- Accession Number
- AD1106371
Entities
People
- Gregory A. Cote
Organizations
- Medical University of South Carolina