Safety and Efficacy of Fully Covered Self-Expandable Metal Stents for Benign Upper Gastrointestinal Strictures Beyond the Esophagus.

Background Stents utilized for pyloric, duodenal, or anastomotic malignant strictures are generally uncovered and are not retrievable. Taewoong Medical created a through-the-scope stent that is fully covered, retrievable, and can be placed beyond the esophagus for benign gastroduodenal strictures as an alternative to surgical approaches. The aim of this paper is to examine the safety and efficacy of short-term, fully covered, self-expanding metal stents (FC-SEMS) in refractory benign strictures of the pylorus, duodenum, and gastrojejunal anastomosis. Methodology This multicenter case series was conducted at four hospitals from January 2018 through December 2020. Patients presenting with benign strictures of the pylorus, duodenum, or gastrojejunal anastomosis were entered into the study. A therapeutic channel scope was utilized to place FC-SEMS to open strictures. The stents were removed a few weeks later. A four-point gastric outlet obstruction scoring system (GOOSS) was used to record improvement. Results Statistically significant improvement in GOOSS was found between the pre-procedure and the four-week follow-up. Conclusions Fully covered, retrievable metal stents appear safe and effective in the management of refractory benign pyloric, duodenal, and anastomotic strictures. This may provide a less invasive option in the management of these strictures compared to surgery.

Utilization of Antireflux Mucosectomy and Resection and Plication: A Novel Approach for the Management of Recurrent Gastroesophageal Reflux Disease after Prior Nissen Fundoplication or Transoral Incisionless Fundoplication.

Background: Nissen Fundoplication (NF) and Transoral Incisionless Fundoplication (TIF) are established procedures for the treatment of gastroesophageal reflux disease (GERD). However, the surgically induced plication can loosen over time. This multicenter study aims to evaluate the safety and efficacy of Antireflux Mucosectomy (ARMS) and Resection and Plication (RAP) in symptomatic patients with prior NF or TIF that has become loose. Patients and methods: Eighteen patients were enrolled in the study. Ten had prior TIF, while eight had prior NF. Half of these patients had a Hill Grade 3 Valve while the other half had a Hill Grade 2 valve. Endoscopic submucosal dissection (ESD) was performed in six patients, while endoscopic mucosal resection (EMR) was performed in twelve patients. A follow-up endoscopy was performed at 4-12 weeks. Results: At follow-up, 11 patients had a Hill Grade 1 valve, and seven patients had a Hill Grade 2 valve. All patients had improvement in symptoms for up to 32 months. Conclusions: In this pilot study, ARMS/RAP appears to be an effective option in patients who had prior NF or TIF with recurrent GERD symptoms.

Endoscopic Ultrasound-Guided Botox Injection for Refractory Anal Fissure.

Background: Anal fissures cause severe pain and can be difficult to treat. Medical therapy is initially used, followed by sigmoidoscopy-guided botox injections if the medical therapy is not successful. With this technique, however, it is not clear whether botox is injected into the muscle layer or submucosa. Aim: To evaluate the efficacy of EUS-guided botox injection directly into the internal sphincter. Methods: Consecutive patients with chronic anal fissure refractory to conventional endoscopic botulinum toxin type A injection were enrolled in the study. EUS was performed using a linear array echoendoscope, and a 25 G needle was used to inject botox. All patients were followed up at one- and two-month intervals. Results: Eight patients with chronic anal fissures were included in the study. Six patients had an excellent response to botox at the two-month interval using a visual analog pain scale, while one patient had a moderate response with a pain score reduction of 40%. One patient had no response. No complications were noted. An improvement in visual analog scale (pre-score > post-score) was statistically significant at the p < 0.01 level. Conclusion: EUS-guided botox injection into the internal sphincter appears to be a promising technique for patients with refractory anal fissure with pain.

Endoscopic management of tumors of minor ampulla: a multicenter study.

Background and study aims Papillary and duodenal carcinoma are aggressive cancers with poor 5-year survival rates. Papillectomy is a well-established treatment for early-stage carcinoma of the major papilla. Tumors arising in the minor papilla are relatively rare and there is little research available on the endoscopic management of these tumors. Patients and methods The purpose of this study was to establish the safety and efficacy of endoscopic papillectomy in the management of minor papillary tumors. A total of six patients undergoing ERCP for papillectomy for minor papillary tumor at four hospitals were included in this study over a period of 5 years. Results Papillectomy was technically successful in all six patients. Pathology revealed adenoma in three patients, adenoma with high-grade dysplasia in one patient, carcinoma in one patient, and carcinoid tumor in one patient. For follow-up, one patient had an additional tumor identified at 2 years which was found to be a recurrence of the original adenoma. This patient was treated with repeat papillectomy with no further evidence of recurrence. Conclusions In our pilot study, we demonstrate that endoscopic papillectomy appears safe and effective in the management of minor papillary tumors.

Safety and efficacy of a novel powered endoscopic debridement tissue resection device for management of difficult colon and foregut lesions: first multicenter U.S. experience.

BACKGROUND AND AIMS: The EndoRotor, nonthermal, powered endoscopic debridement (PED) instrument (Interscope Inc, Whitinsville, Mass, USA), is a novel device used in the GI tract. It uses adjustable suction and a rotary cutting blade to precisely resect mucosal and submucosal tissue. Our aim was to assess the technical feasibility, safety, and efficacy of PED using the EndoRotor device. METHODS: This was an Institutional Review Board-approved, multicenter, retrospective review. Patients underwent PED with the EndoRotor device from August 2018 to September 2019 at 4 high-volume U.S. centers. Patient demographics, indication for PED, and procedural and histopathologic data were recorded. RESULTS: Thirty-four patients underwent PED (41 lesions). The most common indications for PED were colon polyps (18, 52.9%) and Barrett's esophagus (8, 23.5%). Most lesions (35, 85.4%) were resected previously for the same indication using standard techniques. Technical success was achieved in 97.6% of lesions (n = 40). Clinical success was achieved in most patients who underwent a follow-up examination (19, 79.2%). Intraprocedural bleeding (in 10 patients) was managed endoscopically; no EndoRotor-related perforations occurred. Three postprocedural adverse events occurred: self-limited chest pain in 1 patient and delayed bleeding in 2. CONCLUSIONS: The EndoRotor is a novel, effective, and safe PED device for endoscopic resection of flat and polypoid lesions in the colon and foregut. It may have a promising role in the endoscopic management of naïve and scarred mucosal lesions based on this initial experience. Further prospective studies are needed to clarify its role in endoluminal resection.

Rapid Health Impact Assessment of a Proposed Poultry Processing Plant in Millsboro, Delaware.

In 2013, Allen Harim Foods purchased the former site of a Vlasic Pickle plant in Millsboro, Delaware, and proposed to convert the site into a poultry processing plant that would process approximately two million birds weekly. This generated concerns about the proposed plant's potential to impact health and quality of life among residents. We conducted a rapid health impact assessment (HIA) of the proposed plant to assess baseline environmental health issues in the host community and projected impacts. The scoping and baseline assessment revealed social, economic, and health disparities in the region. We also determined that residents in the area were already underserved and overburdened with pollution from multiple environmental hazards near the proposed plant including two sites contaminated with hazardous wastes, a power plant, and another poultry processing plant. The projected size and amount of poultry to be processed at the plant would likely cause increased levels of air, soil and water pollution, additional odor issues, and increased traffic and related pollution and safety issues. The information generated from the HIA formed the basis of a campaign to raise awareness about potential problems associated with the new facility and to foster more engagement of impacted residents in local decision-making about the proposed plant. In the end, the HIA helped concerned residents oppose the new poultry processing plant. This case study provides an example of how HIAs can be used as a tool to educate residents, raise awareness about environmental justice issues, and enhance meaningful engagement in local environmental decision-making processes.

Mechanical colon cleansing for screening colonoscopy: A randomized controlled trial.

OBJECTIVE: Effective screening colonoscopy depends on the quality of colon preparation. This study aimed to compare pulsed irrigation evacuation (PIE), polyethylene glycol (PEG) and sodium phosphate colon preparations. METHODS: Outpatients at a VA hospital were randomized using sealed envelopes. Preparations consisted of polyethylene glycol 4L, Fleet sodium phosphate 90 mL with four to six glasses water twice daily and 296 mL of magnesium citrate in the evening with PIE prior to colonoscopy. Colon cleansing was assessed blindly using a five-point scale: 0 (very poor) to 4 (excellent). RESULTS: Altogether 391 patients participated in the study (129 in the PEG group, 127 in the sodium phosphate and 135 in the PIE group), with a mean age of 62 years, of whom 75% were men. PIE and sodium phosphate were superior to PEG: median cleansing scored 4 (excellent) versus 3 with PEG (P < 0.01). Inadequate preparations were more common with PEG than PIE (18% vs 5%) (P < 0.01). Side-effects included vomiting: 37% in the sodium phosphate group versus 5% in the PEG and 2% in the PIE groups (P < 0.01). The three preparations were judged intolerable in ≤ 5%. CONCLUSIONS: PIE and sodium phosphate are superior to PEG for colon preparations. PIE is the preferred preparation for those at high risk of unsatisfactory preparations or with unsatisfactory traditional preparations.

Papillectomy for ampullary neoplasm: results of a single referral center over a 10-year period.

BACKGROUND: Tumors arising from the duodenal papilla account for approximately 5% of GI neoplasms, but are increasingly identified. OBJECTIVE: To describe the clinical characteristics and outcomes in a large single-center experience with patients referred for ampullary lesions. DESIGN: A retrospective review of the Virginia Mason Medical Center endoscopy and hospital service database. SETTING: Tertiary referral center. PATIENTS: One hundred ninety-three patients referred for ampullary lesions from 1997 to 2007. INTERVENTIONS: Endoscopic management of ampullary lesions. MAIN OUTCOME MEASUREMENTS: The relationship of demographic and clinical data with endoscopic treatment and clinical outcomes in these patients. RESULTS: One hundred ninety-three patients underwent endoscopy for ampullary lesions. Fifteen juxta-ampullary lesions and 10 normal variants were excluded. Among 168 patients, there were 112 (67%) adenomas, 38 (23%) adenocarcinomas, and 18 (10%) nonadenomatous lesions. There were 88 men and 80 women, with a mean age of 64 years. Clinical presentation included cholestasis/cholangitis (72 patients), abdominal pain (54 patients), incidental/asymptomatic (51 patients), pancreatitis (9 patients), and bleeding (7 patients). Of the 57 patients referred to surgery, 42 were sent directly without papillectomy, and 16 were sent after papillectomy. Papillectomies were performed in 102 patients with adenomatous lesions. The mean tumor size was 2.4 cm (range 0.5-6 cm). The papillectomy complication rate was 21%: mild pancreatitis in 10 (10%) patients, cholangitis in 1, retroperitoneal perforation in 1 (adenocarcinoma), intraperitoneal perforation in 1 (lateral extension), bleeding in 5 (lateral extension in 2 of these 5), and delayed papillary stenosis in 3. Recurrences were seen in 8%. The endoscopic success rate was 84%. Factors affecting success were a smaller adenoma size and the absence of dilated ducts. CONCLUSIONS: Most ampullary adenomas are amenable to endoscopy. Underlying malignancy and lateral extension may be risk factors for bleeding and perforation. Smaller lesion size and the absence of dilated ducts are factors favorably affecting success.

Cell proliferation, cell cycle abnormalities, and cancer outcome in patients with Barrett's esophagus: a long-term prospective study.

PURPOSE: Elevated cellular proliferation and cell cycle abnormalities, which have been associated with premalignant lesions, may be caused by inactivation of tumor suppressor genes. We measured proliferative and cell cycle fractions of biopsies from a cohort of patients with Barrett's esophagus to better understand the role of proliferation in early neoplastic progression and the association between cell cycle dysregulation and tumor suppressor gene inactivation. EXPERIMENTAL DESIGN: Cell proliferative fractions (determined by Ki67/DNA multiparameter flow cytometry) and cell cycle fractions (DNA content flow cytometry) were measured in 853 diploid biopsies from 362 patients with Barrett's esophagus. The inactivation status of CDKN2A and TP53 was assessed in a subset of these biopsies in a cross-sectional study. A prospective study followed 276 of the patients without detectable aneuploidy for an average of 6.3 years with esophageal adenocarcinoma as an end point. RESULTS: Diploid S and 4N (G(2)/tetraploid) fractions were significantly higher in biopsies with TP53 mutation and loss of heterozygosity. CDKN2A inactivation was not associated with higher Ki67-positive, diploid S, G(1), or 4N fractions. High Ki67-positive and G(1)-phase fractions were not associated with the future development of esophageal adenocarcinoma (P=0.13 and P=0.15, respectively), whereas high diploid S-phase and 4N fractions were (P=0.03 and P<0.0001, respectively). CONCLUSIONS: High Ki67-positive proliferative fractions were not associated with inactivation of CDKN2A and TP53 or future development of cancer in our cohort of patients with Barrett's esophagus. Biallelic inactivation of TP53 was associated with elevated 4N fractions, which have been associated with the future development of esophageal adenocarcinoma.

Dietary supplement use and risk of neoplastic progression in esophageal adenocarcinoma: a prospective study.

The incidence of esophageal adenocarcinoma (EA) and its precursor condition, Barrett's esophagus, has risen rapidly in the United States for reasons that are not fully understood. Therefore, we evaluated the association between use of supplemental vitamins and minerals and risk of neoplastic progression of Barrett's esophagus and EA. The Seattle Barrett's Esophagus Program is a prospective study based on 339 men and women with histologically confirmed Barrett's esophagus. Participants underwent baseline and periodic follow-up exams, which included endoscopy and self-administered questionnaires on diet, supplement use, and lifestyle characteristics. Use of multivitamins and 4 individual supplements was calculated using time-weighted averages of reported use over the observational period. Cox proportional-hazards models were used to calculate hazard ratios (HR) for each endpoint: EA, tetraploidy, and aneuploidy. During a mean follow-up of 5 yr, there were 37 cases of EA, 42 cases of tetraploidy, and 34 cases of aneuploidy. After controlling for multiple covariates including diet, nonsteroidal anti-inflammatory drug use, obesity, and smoking, participants who took 1 or more multivitamin pills/day had a significantly decreased risk of tetraploidy [HR = 0.19; 95% confidence interval (CI) = 0.08-0.47) and EA (HR = 0.38; 95% CI = 0.15-0.99] compared to those not taking multivitamins. Significant inverse associations were also observed between risk of EA and supplemental vitamin C (> or = 250 mg vs. none: HR = 0.25; 95% CI = 0.11-0.58) and vitamin E (> or = 180 mg vs. none: HR = 0.25; 95% CI = 0.10-0.60). In this cohort study, use of multivitamins and single antioxidant supplements was associated with a significantly reduced risk of EA and markers of neoplastic progression among individuals with Barrett's esophagus.

Leukocyte telomere length predicts cancer risk in Barrett's esophagus.

PURPOSE: Leukocyte telomere length has gained attention as a marker of oxidative damage and age-related diseases, including cancer. We hypothesize that leukocyte telomere length might be able to predict future risk of cancer and examined this in a cohort of patients with Barrett's esophagus, who are at increased risk of esophageal adenocarcinoma and thus were enrolled in a long-term cancer surveillance program. PATIENTS AND METHODS: In this prospective study, telomere length was measured by quantitative PCR in baseline blood samples in a cohort of 300 patients with Barrett's esophagus followed for a mean of 5.8 years. Leukocyte telomere length hazard ratios (HR) for risk of esophageal adenocarcinoma were calculated using multivariate Cox models. RESULTS: Shorter telomeres were associated with increased esophageal adenocarcinoma risk (age-adjusted HR between top and bottom quartiles of telomere length, 3.45; 95% confidence interval, 1.35-8.78; P = 0.009). This association was still significant when individually or simultaneously adjusted for age, gender, nonsteroidal anti-inflammatory drug (NSAID) use, cigarette smoking, and waist-to-hip ratio (HR, 4.18; 95% confidence interval, 1.60-10.94; P = 0.004). The relationship between telomere length and cancer risk was particularly strong among NSAID nonusers, ever smokers, and patients with low waist-to-hip ratio. CONCLUSION: Leukocyte telomere length predicts risk of esophageal adenocarcinoma in patients with Barrett's esophagus independently of smoking, obesity, and NSAID use. These results show the ability of leukocyte telomere length to predict the risk of future cancer and suggest that it might also have predictive value in other cancers arising in a setting of chronic inflammation.

No effect of exercise on colon mucosal prostaglandin concentrations: a 12-month randomized controlled trial.

BACKGROUND: Epidemiologic studies provide evidence that exercise is associated with reduced risk of colon cancer. Exercise may exert protective effects on the colon by influencing prostaglandin production. We hypothesized that an exercise intervention would decrease prostaglandin E(2) concentrations and increase prostaglandin F(2alpha) in colon biopsies compared with controls. METHODS: A 12-month randomized controlled trial testing the effects of exercise on colon mucosal prostaglandin concentrations was conducted in men (n=95) and women (n=89). The exercise intervention included moderate-to-vigorous aerobic activity, 60 min/d, 6 days/wk versus controls. Prostaglandin E(2) and F(2alpha) concentrations were measured in colon biopsies using an enzyme-linked immunoassay at baseline and at 12 months to assess changes in mean concentration for each group. RESULTS: Baseline colon prostaglandin E(2) and F(2alpha) concentrations were not correlated with age, race, education, family history of colon cancer, previous polyps, body size, diet, smoking, nonsteroidal antiinflammatory drug use, metabolic factors, or sex hormone levels. For both men and women, the exercise and control groups showed no change in mean prostaglandin E(2) or F(2alpha) between the baseline and 12-month biopsies. There was no difference in mean prostaglandin concentrations between exercisers and controls when exercisers were grouped by level of intervention adherence. Results were not modified by baseline age, body mass index, percentage of body fat, nonsteroidal antiinflammatory drug use, history of adenomatous polyps, or family history of colon cancer. CONCLUSION: A 12-month moderate-to-vigorous intensity aerobic exercise intervention did not result in significant changes in colon mucosal prostaglandin concentrations.

Longitudinal study of insulin-like growth factor, insulin-like growth factor binding protein-3, and their polymorphisms: risk of neoplastic progression in Barrett's esophagus.

BACKGROUND: Insulin-like growth factor-I (IGF-I) is a potent mitogen. IGF-I and its main binding protein, IGF binding protein-3 (IGFBP-3), and their polymorphisms have been investigated in relation to risk of many cancers, but not esophageal adenocarcinoma. MATERIALS AND METHODS: We used data and specimens from a longitudinal study of persons with Barrett's esophagus (n=344; median, 5.4 years follow up) to determine whether baseline serum concentrations of IGF-I and IGFBP-3 and associated polymorphisms were related to the risk of developing esophageal adenocarcinoma or flow cytometric abnormalities. RESULTS: Overall, circulating concentrations of IGF-I and IGBP-3 were not associated with risk of esophageal adenocarcinoma or flow cytometric abnormalities, with the exception of an approximate tripling of risk of aneuploidy among participants with higher IGFBP-3 levels [above median; adjusted hazard ratio (HR) comparing subjects with levels lower than median versus higher of equal to median, 2.7; 95% confidence interval (95% CI), 1.2-6.0; P=0.01]. Genotypic analyses revealed that persons with the IGF-I [cytosine-adenine (CA)](19) or the IGFBP-3 A-202C C allele were associated with lower circulating concentrations of IGF-I (P(trend)=0.01) and IGFBP-3 (P(trend)=0.002), respectively. Persons with two copies of the IGF-I receptors 2-bp deletion allele had a nonsignificant 2-fold increased risk of tetraploidy (HR, 2.3; 95% CI, 0.9-5.9; P(trend)=0.11). After adjustment for IGFBP-3 levels, participants carrying two IGFBP-3 C alleles had a significantly higher risk of developing aneuploidy (HR, 3.8; 95% CI, 1.0-14.0; P(trend)=0.04) than carriers of A alleles; whereas no associations were observed between the outcomes studied and the IGF-I receptors AGG trinucleotide repeat polymorphism at position 97. CONCLUSION: Our findings, although based on a relatively small number of outcomes and subject to several limitations, indicate a potential role of the complex IGF system in neoplastic progression among persons with Barrett's esophagus.

Effect of a 12-month exercise intervention on the apoptotic regulating proteins Bax and Bcl-2 in colon crypts: a randomized controlled trial.

BACKGROUND: Cellular proliferation and apoptosis (cell death) are highly regulated in the colon as insufficient apoptosis may lead to polyps and cancer. Physical activity decreases risk of colon cancer in observational studies, but the biological basis is not well defined. The objective of this study is to examine the effects of a 12-month aerobic exercise program on expression of proteins that promote (Bax) or inhibit (Bcl-2) apoptosis in colon crypts. METHODS: Two hundred two sedentary participants, 40 to 75 years, were randomly assigned to moderate-to-vigorous intensity exercise for 60 min per day, 6 days per week for 12 months, or usual lifestyle. Colon crypt samples were obtained at baseline and 12 months. Bcl-2 and Bax expression was measured by immunohistochemistry. RESULTS: Bax density at the bottom of crypts increased in male exercisers versus controls (+0.87 versus -0.18; P = 0.05), whereas the ratio of Bcl-2 to Bax at the bottom and middle of crypts decreased as aerobic fitness (VO(2)max) increased (P trend = 0.02 and 0.05, respectively). In female exercisers, Bax density in the middle of crypts decreased (-0.36 versus +0.69; P = 0.03) and Bcl-2 to Bax ratio at the top of crypts increased versus controls (+0.46 versus -0.85; P = 0.03). Bax density in the middle of crypts also decreased as minutes per week of exercise increased (P trend = 0.03). CONCLUSIONS: A 12-month exercise intervention resulted in greater expression of proteins that promote apoptosis at the bottom of colon crypts in men and decreased expression of proteins that promote apoptosis at the middle and top of colon crypts in women. The difference in effect by gender and location of observed changes warrants further study.

Exercise effect on weight and body fat in men and women.

OBJECTIVES: The effect of national exercise recommendations on adiposity is unknown and may differ by sex. We examined long-term effects of aerobic exercise on adiposity in women and men. RESEARCH METHODS AND PROCEDURES: This was a 12-month randomized, controlled clinical trial testing exercise effect on weight and body composition in men (N = 102) and women (N = 100). Sedentary/unfit persons, 40 to 75 years old, were recruited through physician practices and media. The intervention was facility- and home-based moderate-to-vigorous intensity aerobic activity, 60 min/d, 6 days/wk vs. controls (no intervention). RESULTS: Exercisers exercised a mean 370 min/wk (men) and 295 min/wk (women), and seven dropped the intervention. Exercisers lost weight (women, -1.4 vs. +0.7 kg in controls, p = 0.008; men, -1.8 vs. -0.1 kg in controls, p = 0.03), BMI (women, -0.6 vs. +0.3 kg/m(2) in controls, p = 0.006; men, -0.5 kg/m(2) vs. no change in controls, p = 0.03), waist circumference (women, -1.4 vs. +2.2 cm in controls, p < 0.001; men, -3.3 vs. -0.4 cm in controls, p = 0.003), and total fat mass (women, -1.9 vs. +0.2 kg in controls, p = 0.001; men, -3.0 vs. +0.2 kg in controls, p < 0.001). Exercisers with greater increases in pedometer-measured steps per day had greater decreases in weight, BMI, body fat, and intra-abdominal fat (all p trend < 0.05 in both men and women). Similar trends were observed for increased minutes per day of exercise and for increases in maximal oxygen consumption. DISCUSSION: These data support the U.S. Department of Agriculture and Institute of Medicine guidelines of 60 min/d of moderate-to-vigorous physical activity.

Patient satisfaction scores for endoscopic procedures: impact of a survey-collection method.

BACKGROUND: Many endoscopy units administer patient satisfaction surveys. We hypothesized that the survey collection method would affect satisfaction scores. OBJECTIVE: To compare satisfaction scores obtained by using on-site (OS) surveys versus mail-back (MB) surveys. DESIGN: Quasi-randomization based on alternating weeks. SETTING: Teaching hospital. PATIENTS: Patients undergoing elective routine outpatient colonoscopy or upper endoscopy. INTERVENTIONS: Every patient was given an 11-question survey that asked about the patient's satisfaction with the nurses and the physician, wait times, the bowel-preparation process, patient education, procedural comfort, and sedation. Survey collection methods alternated weekly between an OS versus an MB method. MAIN OUTCOME MEASUREMENTS: Satisfaction scores on a Likert scale ranged from 1 (worst) to 7 (best). RESULTS: A total of 1698 subjects were included. The response rate was higher for the OS group (95%) than the MB group (62%). OS scores were significantly higher than MB scores for 5 of 11 questions, which concerned nurse satisfaction, physician satisfaction, bowel-preparation comfort, postprocedure education, and overall satisfaction (Bonferroni adjusted P < .05 for all). Younger patients gave lower scores than older patients for all questions, whereas women gave significantly lower scores than men for bowel-preparation satisfaction. LIMITATIONS: Lack of true randomization and formal validation of the satisfaction survey. CONCLUSIONS: Survey collection methods may bias not only response rates but also satisfaction scores. OS survey collection methods tend to result in higher satisfaction scores than MB methods. This bias should be noted when comparing scores among studies that used different survey collection methods.

NSAIDs modulate CDKN2A, TP53, and DNA content risk for progression to esophageal adenocarcinoma.

BACKGROUND: Somatic genetic CDKN2A, TP53, and DNA content abnormalities are common in many human cancers and their precursors, including esophageal adenocarcinoma (EA) and Barrett's esophagus (BE), conditions for which aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) have been proposed as possible chemopreventive agents; however, little is known about the ability of a biomarker panel to predict progression to cancer nor how NSAID use may modulate progression. We aimed to evaluate somatic genetic abnormalities with NSAIDs as predictors of EA in a prospective cohort study of patients with BE. METHODS AND FINDINGS: Esophageal biopsies from 243 patients with BE were evaluated at baseline for TP53 and CDKN2A (p16) alterations, tetraploidy, and aneuploidy using sequencing; loss of heterozygosity (LOH); methylation-specific PCR; and flow cytometry. At 10 y, all abnormalities, except CDKN2A mutation and methylation, contributed to EA risk significantly by univariate analysis, ranging from 17p LOH (relative risk [RR] = 10.6; 95% confidence interval [CI] 5.2-21.3, p < 0.001) to 9p LOH (RR = 2.6; 95% CI 1.1-6.0, p = 0.03). A panel of abnormalities including 17p LOH, DNA content tetraploidy and aneuploidy, and 9p LOH was the best predictor of EA (RR = 38.7; 95% CI 10.8-138.5, p < 0.001). Patients with no baseline abnormality had a 12% 10-y cumulative EA incidence, whereas patients with 17p LOH, DNA content abnormalities, and 9p LOH had at least a 79.1% 10-y EA incidence. In patients with zero, one, two, or three baseline panel abnormalities, there was a significant trend toward EA risk reduction among NSAID users compared to nonusers (p = 0.01). The strongest protective effect was seen in participants with multiple genetic abnormalities, with NSAID nonusers having an observed 10-y EA risk of 79%, compared to 30% for NSAID users (p < 0.001). CONCLUSIONS: A combination of 17p LOH, 9p LOH, and DNA content abnormalities provided better EA risk prediction than any single TP53, CDKN2A, or DNA content lesion alone. NSAIDs are associated with reduced EA risk, especially in patients with multiple high-risk molecular abnormalities.

Extent of low-grade dysplasia is a risk factor for the development of esophageal adenocarcinoma in Barrett's esophagus.

OBJECTIVES: Previous studies that evaluated extent of high-grade dysplasia (HGD) as a risk factor for esophageal adenocarcinoma (EA) in Barrett's esophagus (BE) were conflicting, and no prior study has evaluated extent of low-grade dysplasia (LGD) as a risk factor. The aim of this discovery study was to evaluate the hypothesis that extent of LGD and HGD are risk factors for progression to EA. METHODS: We evaluated baseline biopsies from 77 BE patients with dysplasia including 44 who progressed to EA and 33 who did not progress during follow-up. The total numbers of LGD and HGD crypts were determined separately by counting all crypts and the extent of LGD, HGD, and total dysplasia were correlated with EA outcome. RESULTS: Thirty-one and 46 patients had a maximum diagnosis of LGD and HGD, respectively. When the crypts were stratified by dysplasia grade, the mean number of LGD crypts per patient was borderline higher in progressors (93.9) compared with nonprogressors (41.2, P= 0.07), and the mean proportion of LGD crypts per patient was significantly higher in progressors (46.4%vs 26.0%, P= 0.037). Neither the mean number of HGD crypts per patient (P= 0.14) nor the mean proportion of HGD crypts per patient (P= 0.20) was significantly associated with EA outcome. CONCLUSIONS: The extent of LGD is a significant risk factor for the development of EA in BE in this study. Although the presence of HGD is significantly associated with a greater relative risk for development of EA, the extent of HGD was not an independent risk factor for progression.

Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux.

BACKGROUND: Esophageal capsule endoscopy (ECE) is an alternative to EGD for Barrett's esophagus screening. A multicenter study found ECE to be safe, well tolerated, and accurate; however, a post hoc adjudication process was used that may have biased results. OBJECTIVE: To assess the accuracy of ECE for the diagnosis of Barrett's esophagus. DESIGN: Prospective and blinded, with no adjudication. PATIENTS: Screening patients with chronic gastroesophageal reflux and surveillance patients with known Barrett's esophagus. INTERVENTIONS: ECE followed by EGD in each subject. MAIN OUTCOME MEASUREMENTS: Sensitivity, specificity, and positive and negative predictive values of ECE for Barrett's esophagus by using EGD results, with histologic confirmation as the criterion standard. RESULTS: Ninety-six subjects were enrolled, of whom 90 (94%) completed the study, including 66 screening and 24 surveillance patients. ECE was 67% sensitive and 84% specific for identifying Barrett's esophagus, diagnosing 14 of 21 cases of biopsy-confirmed Barrett's esophagus. Positive and negative predictive values were 22% and 98%, respectively (calculated for screening patients only). Sensitivity for short- and long-segment Barrett's esophagus was similar. CONCLUSIONS: Our blinded, unadjudicated study shows that ECE had only moderate sensitivity and specificity for identifying Barrett's esophagus. ECE in its present form is not suitable as a primary screening tool for Barrett's esophagus but may be used in patients unwilling to undergo EGD. Inadequate visualization of the gastroesophageal junction may be the cause of suboptimal ECE accuracy; this may be improved by advances in ingestion protocol and capsule calibration.