Anthony Infantolino

BACKGROUND: Barrett's esophagus, a condition of intestinal metaplasia of the esophagus, is associated with an increased risk of esophageal adenocarcinoma. We assessed whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett's esophagus and decrease the rate of neoplastic progression. METHODS: In a multicenter, sham-controlled trial, we randomly assigned 127 patients with dysplastic Barrett's esophagus in a 2:1 ratio to receive either radiofrequency ablation (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of Barrett's esophagus. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia. RESULTS: In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, as compared with 22.7% of those in the control group (P<0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0% of those in the ablation group, as compared with 19.0% of those in the control group (P<0.001). Overall, 77.4% of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3% of those in the control group (P<0.001). Patients in the ablation group had less disease progression (3.6% vs. 16.3%, P=0.03) and fewer cancers (1.2% vs. 9.3%, P=0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients (6.0%) had esophageal stricture. CONCLUSIONS: In patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression. (ClinicalTrials.gov number, NCT00282672.)

BACKGROUND: Although studies suggest that inflammatory bowel disease (IBD) has a significant impact on an individual's health-related quality of life, the added weight of other health conditions and comorbidities has not been investigated. The purpose of this study was to expand on prior research by taking into account the impact of other chronic health conditions on the health-related quality of life of individuals with IBD, and to develop a model to help clinicians understand the relative impact of various predictors of their patients' physical and mental health-related quality of life. METHODS: 615 patients from the gastroenterology outpatient practice of a large, urban university hospital received a self-administered survey including questions about their health conditions, the severity of their bowel symptoms, and their health-related quality of life (measured using the SF-36 instrument). RESULTS: 314 completed surveys were returned, resulting in a response rate of 51.1%. Two regression analyses were conducted to identify the role of patient demographic variables and other chronic conditions on the 2 primary outcomes of interest: the SF-36 Physical Component and Mental Component Summary scores. Statistically significant predictors of physical quality of life included IBD disease severity, arthritis, heart disease, age, anemia, back/shoulder pain, and hypertension; statistically significant predictors of mental health-related quality of life were IBD disease severity, depression/anxiety, age, and headaches. CONCLUSIONS: IBD disease severity is the most important predictor of both physical and mental health-related quality of life in patients with this condition despite the presence of other chronic conditions.

Background & AimsThe goal of treatment for Barrett’s esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial.MethodsParticipants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence.ResultsOf 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92%) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32%) patients had recurrence of BE or dysplasia, and 19 (17%) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95% CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95% CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined.ConclusionsIn this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance. The goal of treatment for Barrett’s esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial. Participants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence. Of 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92%) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32%) patients had recurrence of BE or dysplasia, and 19 (17%) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95% CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95% CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined. In this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance.