On Tuesday, May 19, at Digestive Disease Week, the primary national meeting of digestive specialists, MUSC’s Digestive Disease Center announced the start of a new research study designed to examine improved palliative treatments for patients with advanced esophageal cancer.

The randomized trial will compare clinical outcomes of at least 300 patients treated with a self-expanding esophageal stent (Ultraflex™) versus what is now considered standard therapy—palliative radiation. Patients will be enrolled in 15 medical centers in the United States, Canada and Europe.

Digestive Disease Week is the annual meeting of the American Association for the Study of Liver Diseases (AASLD), the American Gastro-enterological Association, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract. The meeting was held in New Orleans, May 17-20.

Nearly 11,000 people in the United States are diagnosed with esophageal cancer each year. At least 50 percent of those cases are considered too advanced to cure, and treatment emphasis is placed on alleviating symptoms and improving quality of life. Dysphagia, or difficulty in swallowing, has proven to be the most important symptom affecting the quality of life in patients with esophageal cancer.

“A number of palliation methods are available to improve a patient’s ability to swallow; however, few comparative studies have been designed to assess how these therapies ultimately affect a patient’s overall quality of life—the main goal of palliative treatment,” says Peter Cotton, M.D., director of the Digestive Disease Center at MUSC and chairman of the S.O.R.T.I.E. Trial Group. “Since these patients have a median survival of about six months, it is important to minimize time spent in treatments and to maximize quality time at home. This study will help us evaluate treatment options based on issues most important to the patients.”

Radiation therapy has been used for decades and in standard doses has shown to relieve dysphagia in 50-70 percent of patients. Higher doses give better palliation but require prolonged treatment. Potential side-effects include inflammation of the esophagus and lung, and stricture formation of the esophagus.

Stents—devices placed through the mouth at endoscopy to support the esophagus and hold back the malignancy—have been used with some success for several years. However, the early non-expandable plastic or rubber stents did not gain wide acceptance as they are difficult to place and result in a high rate of complications. In addition, patients receiving non-expandable stents must adhere to a puree-type diet.

Recent improvements in stent design include self-expanding devices that can be positioned across the tumor before release, making placement easier and reducing the risk of serious complications (such as perforation). Due to these factors and the high rate of efficacy, expandable stents are becoming the preferred method for endoscopic palliation of esophageal cancer in the United States. The stent selected for the MUSC study is the Ultraflex™ esophageal stent, manufactured by Boston Scientific/Microvasive.

The S.O.R.T.I.E. (Stent Or Radiation Therapy Intervention for Esophageal Cancer Dysphagia) trial will measure and compare the following criteria: time to acceptable swallowing; duration and frequency of palliative treatment and diagnostic procedures; complications; number of in-hospital days and frequency of admissions; utilization of outpatient medications; average quality of life; and cost. The study will be coordinated by the Clinical Innovation Group of the MUSC's Foundation for Research Development.

Funding for the S.O.R.T.I.E. trial will be provided, under an educational grant, by Boston Scientific/Microvasive.

The mission of the Digestive Disease Center at MUSC is to provide courteous and cost-effective care for patients with digestive disorders and to provide a springboard for the clinical research and education necessary to enhance it.