Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.

Selenoprotein levels in patients with colorectal adenomas and cancer.

OBJECTIVES: Selenium is a trace mineral that, as a constituent of certain selenoproteins, acts as an antioxidant. Results of studies addressing a cancer protective effect of selenium have been controversial. The present study measured selenoprotein-P, extracellular glutathione peroxidase, and plasma selenium in patients with colon cancer and adenomatous colon polyps to determine whether patients who develop colorectal adenomas or cancer are selenium deficient. METHODS: Patients who presented to an endoscopy center for colonoscopy or who were referred to our institution with a newly diagnosed colorectal cancer were offered enrollment in the trial. Each patient underwent phlebotomy, usually immediately after colonoscopy. In all, 103 patients were enrolled in the study. Of these, 33 patients were found to have colorectal cancer, 35 adenomatous colon polyps, and 17 normal examinations. A total of 18 patients had other diagnoses and were not included in the study group. RESULTS: The mean age for the colorectal cancer group was 69 yr, for the adenomatous colon polyp group 62 yr, and for the normal group was 56 yr. The adenomatous colon polyp and normal groups were predominantly female. Based on one way analysis of variance tests, there was no significant difference in selenoprotein-P or plasma selenium levels or extracellular glutathione peroxidase activity among the three groups (p = 0.28, 0.098, and 0.35 respectively). CONCLUSIONS: The present data suggest that patients with adenomatous colon polyps and those with colorectal cancer are not selenium deficient.