DHMC Physicians' Study Featured in New England Journal of Medicine

Two DHMC physicians recently completed a study which shows non-surgical treatment for a pre-cancerous condition of the esophagus is effective and reduces the risk for developing cancer. Richard Rothstein, MD, Chief of the Section of Gastroenterology and Hepatology and Professor of Medicine at Dartmouth Medical School (DMS), and Stuart Gordon, MD, Director of Endoscopy and Associate Professor of Medicine at DMS, helped determine that the use of radiofrequency ablation is highly effective for complete eradication of a pre-cancerous condition of the esophagus called Barrett’s esophagus. The study entitled "Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia" was featured in the May 28 New England Journal of Medicine, and included DHMC as one of 19 participating study sites.

The study found ablative therapy using the HALO system (BARRX Medical, Inc.) reduced the risk of progression to cancer in the highest risk cohort studied (compared to control) from 19.0% to 2.4%. “This is a well-designed trial conducted in a rigorous manner at 19 expert U.S. centers, each having experience in the management of Barrett’s esophagus, dysplasia, and cancer,” said lead investigator Nicholas J. Shaheen, M.D., Associate Professor of Medicine and Epidemiology at the University of North Carolina in Chapel Hill. “Our results reported in the Journal are very promising, demonstrating superiority of ablation therapy for eliminating Barrett’s and dysplasia, as well as reducing the rate of disease progression to more severe forms of dysplasia and esophageal cancer. This and data from other recent trials may ultimately change the paradigm for how gastroenterologists manage their patients with this disease.”

As a result of chronic injury from gastroesophageal reflux disease (GERD), the normal esophageal lining can be replaced with intestinal type cells (Barrett’s tissue), predisposing the patient to a higher risk for developing cancer of the esophagus. Patients with Barrett’s who develop cancer, typically do so through a series of steps, starting with non-dysplastic Barrett’s, then low-grade dysplasia or high-grade dysplasia, and then finally cancer. Dysplasia is found when tissue samples (biopsies) are analyzed microscopically and the degree of dysplasia reflects changes in the normal cell architecture.

Beginning in 2006, the AIM Dysplasia Trial enrolled 127 patients having a diagnosis of Barrett’s esophagus with the later stages of low- and high-grade dysplasia. Patients were randomly assigned to receive either endoscopic ablation with the HALO system or a sham intervention (control, no radiofrequency treatment), and both groups took daily acid suppressing medication. Biopsies were obtained from the esophagus at regular intervals for one year after enrollment to assess for the presence of any remaining or recurrent Barrett’s, dysplasia, and/or esophageal cancer. Comparison of the biopsy results at one year served as the primary outcome for the trial. The study endpoints were the eradication of all Barrett’s tissue and, separately, all dysplasia in each group, as well as occurrence of new esophageal cancers.

At one-year follow-up, patients treated with ablation had a significantly higher complete eradication rate for both early Barrett’s and dysplasia as compared to the control group. More than three quarters of treated patients had no detectable Barrett’s at the end of the treatment period, compared to sham patients where 98% had persistent disease. The overall rate of disease progression to more severe forms of dysplasia and cancer was significantly lower in the ablation treatment group (3.6%) as compared to the control group (16.3%). In the highest risk cohort (high-grade dysplasia), ablative therapy significantly reduced the risk of progression to cancer by nearly 90% compared to control (2.4% in treated patients versus 19.0% in untreated controls).

At work at DHMC

According to Rothstein, patients with reflux and heartburn are at risk for being diagnosed with Barrett’s esophagus. “There are 17 million Americans with daily heartburn and obviously many of them are in our region. Interestingly, even individuals with no heartburn, but with regurgitation or even silent reflux are at risk and do not know it,” Rothstein said, noting Barrett’s can only be discovered with an upper endoscopy. “The highest risk group is white males in their 40’s, 50’s and 60’s with long-standing heartburn, but any individual with a significant reflux history should be considered for an upper endoscopy.”

Rothstein said ablation by previous methods has been a sanctioned therapy for Barrett's with dysplasia, and the radiofrequency procedure is the newest, most effective and safest option for treating this pre-cancerous condition. “Surgery used to be the ‘knee-jerk’ treatment for dysplastic Barrett's in the past, and it carries an unacceptable morbidity and even mortality. Patients now have a minimally invasive outpatient option to get rid of the pre-cancerous Barrett's esophagus,” Rothstein said.

Rothstein said, “DHMC is among the most experienced GI centers in the country when it comes to treating Barrett’s with this new technology. We have now treated more than 100 patients with Barrett’s esophagus and completed more than 300 treatment sessions. Our ablation results have been even better than the study group results in the New England Journal paper. We have been presenting the outcomes of our DHMC clinical experience at many national and international endoscopy society meetings. This outpatient treatment involves a skilled team approach, and I particularly want to highlight the role of Linda Fadden, a DHMC endoscopy nurse who not only joins Stuart Gordon and me for nearly every treatment session, but has enthusiastically helped to train visiting teams of nurses and doctors who are learning this new technique. Many of the Barrett’s patients need endoscopic ultrasound studies before treatment, and Stuart Gordon, along with Drs. Tim Gardner and Heiko Pohl (both Assistant Professors of Medicine) provide this highly technical diagnostic procedure at DHMC."

Rothstein said institutions in Boston, MA, Manchester and Portsmouth, NH, Portland, ME, and Burlington, VT, are just beginning their experience with this new treatment, and DHMC continues to serve as a referral center for patient care and training in the management of Barrett’s esophagus.