Dr Virender Sharma and colleagues from Arizona assessed the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus.
The researchers used an endoscopic balloon-based ablation device that delivered a pre-set amount of energy density to Barrett's tissue.
The researchers conducted the study in 2 serial phases at 8 centers between 2003 and 2005.
The first phase included the dosimetry phase, which evaluated the dose-response and the safety of delivering 6 to 12 J/cm2 in 32 patients.
The second was the effectiveness phase, and used 10 J/cm2 in 70 patients.
|There was a complete response for Barrett's in 70% of patients|
The procedures were delivered twice for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months.
The researcher performed a second ablation procedure if Barrett' esophagus was present at 1 or 3 months.
Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter.
The team quantified postablation symptoms by using a 14-day symptom diary.
The researchers defined a complete response as all biopsy specimens negative for Barrett's esophagus at 12 months.
Patients were 18 to 75 years of age, with a diagnosis of Barrett's esophagus and without dysplasia.
The patients had histopathology reconfirmation of the diagnosis within 6 months of enrollment.
Median symptom scores returned to a score of 0 of 100 by day 3 in the dosimetry phase.
The team observed no dose-related serious adverse events.
The outcomes at 1 and 3 months permitted the selection of 10 J/cm2 for the subsequent effectiveness phase of the study.
During the effectiveness phase, the team noted that median symptom scores returned to a score of 0 of 100 by day 4.
At 12 months, the researchers achieved a complete response for Barrett's esophagus in 70% of patients.
The researchers found no strictures, and no buried glandular mucosa in either study phase.
Dr Sharma's team concludes, “Circumferential ablation of nondysplastic Barrett's esophagus by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands.
“This method completely eliminates Barrett's esophagus in 70% of patients at 1-year follow-up.”