EPISOD Study Reaches Enrollment Goal; FRAMES Expected to be Largest of Its Kind
November 12, 2012 After four years of intense enrollment by sites nationwide, Dr. Peter Cotton's NIH-Funded EPISOD study (Evaluating Predictors in Sphincter of Oddi Dysfunction) earlier this year reached its enrollment goal of 214 patients. The main purpose of the study is to determine whether sphincterotomy is safe and effective in patients with suspected Sphincter of Oddi Dysfunction type III and determine predictors of response.
Preparations are underway to present some detailed baseline data and the randomized data will be analyzed after the last patient enrolled completes his/her one-year follow-up. The EPISOD study will yield even more exciting results over the next few years as the study patients continue to be followed and even more valuable information is gained regarding the robustness of treatment responses.
Congratulations to Dr. Joseph Romagnuolo, whose NIH-Funded FRAMES study (Frequency of Recurrent Acute pancreatitis after Minor papilla Endoscopic Sphincterotomy) recently completed enrollment in its pilot study and the preliminary results are very encouraging. The pilot study was used to: (i) determine the annual number of patients with pancreas divisum and recurrent pancreatitis that would be eligible for a multicenter randomized trial of endoscopic therapy in pancreas divisum; (ii) assess the accuracy of imaging for eligibility determination; and, (iii) track their short-term outcomes.
Dr. Romagnuolo, who serves as the Director of Clinical Research for MUSC's Digestive Disease Research Center, stated "This prospective series is already the largest performed, and the randomized trial to follow will almost certainly be the largest study of its kind involving sites from around the country."
Digestive research is also active with other parts of the Division of Gastroenterology and Hepatology and many other clinical research studies are being pursued or are actively enrolling.
Recently, two grant proposals were submitted requesting $279,562 in total costs and three grants were awarded totaling $364,407. Thank you to everyone involved in obtaining these awards.