OAK BROOK, Ill. – October 16, 2012 – A new study shows that endoscopic mucosal resection (EMR) before radiofrequency ablation (RFA) is a safe and effective treatment option for patients with nodular Barrett's esophagus (BE) and advanced neoplasia. The performance of EMR before RFA was not associated with a diminished likelihood of success of therapy or an increased rate of stricture compared with those with advanced neoplasia undergoing RFA alone. The study appears in the October issue of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy (ASGE).
Barrett's esophagus is a precancerous condition associated with cancer of the esophagus, a condition with a marked increase in incidence over the past four decades. BE with high-grade dysplasia (HGD, abnormal cells) may progress to cancer in as many as 20 percent of patients per year. Similarly, BE with intramucosal carcinoma (IMC) is a high-risk lesion in the absence of disease altering therapy. Radiofrequency ablation is a safe and effective therapy for the eradication of nonnodular dysplastic BE. However, many patients with HGD or IMC have nodularity (a small mass of tissue in the form of a knot, swelling or protuberance, either normal or pathological) in their BE segment. EMR is commonly performed to remove these nodular areas before treatment with RFA. Although RFA and EMR are frequently performed, their safety and efficacy are poorly understood.
"The aims of this study were to compare the safety and efficacy of combined EMR/RFA treatment for nodular BE with that of treatment with RFA alone for nonnodular BE. We assessed whether preceding EMR leads to either a higher complication rate or decreased efficacy in comparison with patients requiring RFA alone," said study lead author Nicholas Shaheen, MD, MPH, University of North Carolina, Chapel Hill. "In patients treated with EMR before RFA for nodular BE with HGD or IMC, no differences in efficacy and safety outcomes were observed compared with RFA alone for nonnodular BE with HGD or IMC. EMR followed by RFA is safe and effective for patients with nodular BE and advanced neoplasia. To our knowledge, this study represents the largest published cohort of patients with BE and advanced neoplasia treated with EMR before RFA for nodular BE."
About EMR and RFA
EMR is a technique in which superficial abnormal tissue is resected (removed) endoscopically from the deeper tissue layers. The abnormal tissue can then be sent to a pathologist for evaluation. Mucosal ablative techniques are methods of destroying the superficial lining, or "mucosa," of the gastrointestinal tract. This is usually done when there are precancerous changes which need to be treated. Once the superficial, diseased mucosal layer is destroyed, a new, healthy layer regenerates. A newer method of ablation is called radiofrequency ablation. One radiofrequency device has been developed specifically for ablation of Barrett's esophagus. This is a cylinder shaped balloon passed over a guidewire. Once in position, the balloon is inflated, bringing its wall into contact with the precancerous Barrett's mucosa. The physician presses a foot pedal and radiofrequency energy is delivered over the entire surface area of the balloon. The delivery of the energy takes about one second and results in a very superficial burn of the esophageal lining. Once the Barrett's tissue sloughs off, a new, healthy esophagus lining grows back.
The study objective was to determine the efficacy and safety of EMR before RFA for nodular BE with advanced neoplasia (high-grade dysplasia or intramucosal carcinoma). It was a retrospective study conducted at the University of North Carolina Hospitals from 2006 to 2011. A total of 169 patients with BE with advanced neoplasia were included in the study: 65 patients treated with EMR and RFA for nodular disease and 104 patients treated with RFA alone for nonnodular disease. The main outcome measurements were efficacy (complete eradication of dysplasia, complete eradication of intestinal metaplasia, total treatment sessions, and RFA treatment sessions), and safety (stricture formation, bleeding, and hospitalization).
EMR followed by RFA achieved complete eradication of dysplasia and complete eradication of intestinal metaplasia in 94 percent and 88 percent of patients, respectively, compared with 82.7 percent and 77.6 percent of patients, respectively, in the RFA-only group. The complication rates between the two groups were similar: 7.7 percent vs 9.6 percent. Strictures occurred in 4.6 percent of patients in the EMR-before-RFA group compared with 7.7 percent of patients in the RFA-only group.
The researchers concluded that RFA after EMR is a safe and effective treatment option for patients with nodular BE and advanced neoplasia. In this cohort, the performance of EMR before RFA was not associated with a diminished likelihood of success of therapy or an increased rate of stricture compared with those with advanced neoplasia undergoing RFA alone. The researchers noted that further studies are necessary to determine the effects of EMR before RFA on the durability of RFA treatment and to determine the effects of multiple EMR sessions on RFA outcomes.
In an accompanying editorial, David E. Fleischer, MD, Division of Gastroenterology, Mayo Clinic in Arizona, Scottsdale, stated "…this well-designed and well-executed study provides information for safety and efficacy and that allows us to continue to follow these now accepted treatment strategies with more comfort that one is doing the right thing."
About the American Society for Gastrointestinal Endoscopy
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with more than 12,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system.
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