ROCHESTER, Minn. -- Studies led by Piet de Groen, M.D., and William Sandborn, M.D., of the Mayo Clinic Division of Gastroenterology and Hepatology, will be honored today at the American College of Gastroenterology Annual Scientific Meeting. Their work, in collaboration with other researchers, represents two of the five abstracts selected for the 2006 American College of Gastroenterology (ACG) Governor's Awards for Excellence in Clinical Research. Drs. de Groen and Sandborn will present their findings today at the ACG President's Plenary Session.
Groundbreaking Quality Control Work: Dr. de Groen's collaborative has developed a novel method to digitally capture, store, and analyze a complete video stream file created during colonoscopy. The software can automatically extract five quality measures from the digitized video files. "I'm not aware of any other software that can automatically analyze what a physician does during colonoscopy and provide objective data to the physician in a report. In other words, this is the first time a computer in completely automated fashion has been used to grade a procedure and thereby grade a physician," Dr. de Groen says.
Background: This collaborative began its work four years ago and is funded in part through a National Science Foundation grant for research of new methods of automated image analysis in endoscopy. The purpose of the research was to develop a method to gather objective data that could explain why large polyps and cancers are not always detected during colonoscopy. The researchers created approximately 250 digital video files during colonoscopy and extracted five objective quality control metrics using novel software.
Research Applications: Research applications include the potential to provide large-scale, continuous quality control for colonoscopy in the day-to-day medical practice setting and the ability to assess progress during colonoscopy training or as part of endoscopic skills assessment. Colonoscopy is the best diagnostic tool currently available for colon cancer detection and is recommended for everyone beginning at age 50.
Collaboration and Support: Others on the research team include JungHwan Oh, Ph.D., Department of Computer Science and Engineering, University of North Texas, Denton; Wallapak Tavanapong, Ph.D., and Johnny Wong, Ph.D., Department of Computer Science, Iowa State University, Ames. This work was supported in part by grants from the National Science Foundation, a Clinical Practice Innovation Award from Mayo Clinic, the Miles and Shirley Fiterman Endowment Fund for Digestive Diseases, the Grow Iowa Value Fund, and Iowa State University.
Alternative Option for Treating Crohn's Disease -- GAIN Study Design: Dr. Sandborn was the lead investigator of a multicenter study (GAIN -- gauging adalimumab efficacy in infliximab nonresponders) which found that a new drug, adalimumab (Humira), was able to induce clinical remission in patients with moderate to severe Crohn's disease who previously responded to infliximab (Remicade) and then became allergic or lost response. Infliximab is a chimeric (contains both mouse and human protein) monoclonal antibody to tumor necrosis factor (TNF). Adalimumab is a human (contains human protein only) monoclonal antibody to TNF. Because Adalimumab is structurally similar to naturally occurring human antibodies, it may be less likely to be rejected by the immune system.
A total of 325 patients with moderate to severe Crohn's disease participated in the four-week study which was conducted between November 2004 and December 2005. The patients were divided into two groups. One hundred and sixty-six patients were given a placebo and 159 patients were given 160 mg of adalimumab at week one and 80 mg the second week of the study.
Study Results:
Results of the GAIN Study, sponsored by Abbott Laboratories, show that adalimumab is an effective and safe alternative for patients. This positive effect was observed as early as week one. At week four, 21 percent of patients receiving adalimumab were in remission as compared with 7 percent of those who received the placebo. Response was induced at week four in 52 percent of patients in the adalimumab group as compared with 34 percent of patients in the placebo group. Adalimumab was well tolerated by the patients in the study, with an overall similar incidence of adverse events compared to those patients who received the placebo.
Impact of Research:
"The group of patients with the greatest medical need are those patients who have tried other treatment options with the exception of surgery," says Dr. Sandborn. "Our data indicate that adalimumab is a new effective and safe treatment option for these patients."
Collaboration and Support:
Other members of the collaborative are Paul Rutgeerts, M.D., Ph.D., Universitaire Ziekenhuizen Leuven, UZ Gasthuisberg, Leuven, Belgium; Robert Enns M.D., Gastroenterology Clinic, Vancouver, British Columbia, Canada; Stephen Hanauer M.D., University of Chicago; Jean Frederic Colombel M.D., L'hôpital Claude Huriez, Centre Hospitalier Universitare de Lille, France; Remo Panaccione, M.D., University of Calgary, Alberta, Canada; Jeffery Kent, M.D., Abbott Laboratories, Abbott Park, Ill.; and Paul Pollack, M.D., Abbott Laboratories, Parsippany, N.J.
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