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Procedure promising for esophogeal cancer

by Heather Woolwine
Public Relations
A clinical trial under way at MUSC may provide further proof that one company’s procedure for eliminating Barrett’s esophagus decreases the chance of developing esophageal cancer.
 
Early results from studies like the one led by Robert Hawes, M.D., and Brenda Hoffman, M.D., College of Medicine professors, have demonstrated that the Barrett’s esophageal tissue was completely removed and replaced by normal, healthy tissue in the majority of the procedures performed. It is deemed as the latest inpatient treatment.
 
It would be difficult to find someone who has never experienced heartburn—the results of eating that extra enchilada or Mom’s to-die-for chocolate cake. While most people only have to deal with the occasional case, others are plagued with a life-long condition that emerges when stomach acid backs up into the esophagus more frequently. This condition is known as Gastroesophageal Reflux Disease (GERD). Chronic GERD leads to increased risk of developing esophageal cancer.
 
Esophageal cancer has grown more than 600 percent in the past two decades, according to the American Cancer Society, and Hoffman noted the rise in rates for South Carolina is comparable. Combine risk factors, like smoking or drinking alcohol, with Barrett’s esophagus, and this kind of cancer is a real threat for many South Carolinians.
 
Researchers now understand that developing GERD may put individuals at increased risk of developing a change in the lining of the, known as Barrett’s esophagus. Those diagnosed with the condition are 25 times more likely to develop esophageal cancer adenocarcinoma, a frequently fatal form of cancer, than those without Barrett’s.
 
Patients with Barrett’s esophagus may develop precancerous changes called dysplasia. Selected patients with dysplasia are recommended to have their esophagus removed to avoid progression to esophageal cancer, while others may be candidates for a new endoscopic procedure to remove the diseased tissue.
 
For the clinical trial of Barrx’s Halo-360 System, Hawes and Hoffman are  recruiting patients with either a high or low degree of dysplasia associated with Barrett’s.
 
“The advantages of the treatment compared to more traditional approaches are that it is less invasive and doesn’t cause as many complications as photodynamic therapy,” Hoffman said. “In PDT, which involves giving a patient a light-sensitive drug and burning away affected tissue with a laser, the abnormal tissue is burnt from the esophageal wall. In some patients, the burn would go all the way through the esophageal wall and those complications were cause for extra treatment and pain. Plus, sometimes with PDT, Barrett’s can come back.”
 
With the Halo-360 system, the depth of the burn is more superficial, Hoffman added. Previously, patients had only the options of PDT, endoscopic removal, or a surgical procedure known as an esophagectomy. During that surgery, a portion of the esophagus is cut out and the remaining part is reattached to the stomach. While surgery is definitive, it has associated morbidity and mortality. Hoffman explained that removing the lining of the esophagus with instruments via an endoscope was excellent therapy “when all goes well, and the results are fantastic; otherwise it becomes a nightmare requiring invasive surgery in the chest.”    
 
The new procedure is performed on an outpatient basis under conscious sedation. Earlier trials showed it can eliminate Barrett’s in 75 percent of patients whose progress was followed for six to seven months, according to Barrx’s Web site. Based on radio frequency energy, treatment with the Halo-360 involves placing a sizing balloon into a patient’s esophagus, followed by a catheter that is inflated against the affected tissue. A burst of energy is then delivered through a generator that ablates, or destroys, a very thin layer of the diseased esophagus. Barrx said that healthy tissue has been shown to grow back in three to four weeks.
 
In Hoffman’s study, researchers will look at the treatment in patients with low and high levels of dysplasia and then randomize study participants who may or may not receive the new treatment. All participants receive an aggressive acid-blocking medication to minimize discomfort. Once the study is concluded and results are accessed, patients who did not receive the procedure during the study will then get the real thing.
 
So far, the study has had a 90-percent success rate of patients with low and high dysplasia who have undergone the treatment. In addition, the new technique is user-friendly for gastroenterologists with seemingly no reformation of Barrett’s once the procedure is completed (normally in one or two sessions). Patients who undergo the procedure can expect some chest pain and discomfort for up to three days afterwards.
 
Hoffman hopes to meet full enrollment for the study by September and will follow study patients for several years beyond their procedures to explore any possible long-term sequella and outcomes.
 
To enroll or find out more about the study, contact Tammy Glenn through Health Connection at 792-1414.
   

Friday, June 9, 2006
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