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BACKGROUND: Remote manipulation of wireless capsule endoscopes might improve diagnostic accuracy and facilitate therapy. OBJECTIVE: To test a new capsule-manipulation system. SETTING: University hospital. DESIGN AND INTERVENTIONS: A first-in-human study tested a new magnetic maneuverable wireless capsule in a volunteer. A wireless capsule endoscope was modified to include neodymium-iron-boron magnets. The capsule's magnetic switch was replaced with a thermal one and turned on by placing it in hot water. One imager was removed from the PillCam colon-based capsule, and the available space was used to house the magnets. A handheld external magnet was used to manipulate this capsule in the esophagus and stomach. The capsule was initiated by placing it in a mug of hot water. The capsule was swallowed and observed in the esophagus and stomach by using a gastroscope. Capsule images were viewed on a real-time viewer. MAIN OUTCOME MEASUREMENTS: The capsule was manipulated in the esophagus for 10 minutes. It was easy to make the capsule turn somersaults and to angulate at the cardioesophageal junction. In the stomach, it was easy to move the capsule back from the pylorus to the cardioesophageal junction and hold/spin the capsule at any position in the stomach. The capsule in the esophagus and stomach did not cause discomfort. LIMITATIONS: Magnetic force varies with the fourth power of distance. CONCLUSIONS: This study suggests that remote manipulation of a capsule in the esophagus and stomach of a human is feasible and might enhance diagnostic endoscopy as well as enable therapeutic wireless capsule endoscopy. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. [ABSTRACT FROM AUTHOR]

BACKGROUND: Endoscopic submucosal dissection (ESD) is a minimally invasive method for en bloc removal of GI lesions. Current ESD methods and devices have limitations, including long procedure times, technical difficulty, safety, and availability. OBJECTIVE: The aim of this study was to evaluate a blunt submucosal dissection technique and compare it with ESD by using the insulated-tip (IT) knife. DESIGN: Randomized, controlled, animal study. SETTING: Animal facility laboratory. INTERVENTION: Twelve gastric lesions were marked by using electrocautery. After submucosal injection, a circumferential mucosal incision was created. ESD was then performed by using either the IT knife 2 (n = 6) or the flexible endoscopic Maryland dissector (n = 6). MAIN OUTCOME MEASUREMENTS: Median time for IT knife ESD versus median time for Maryland dissector ESD. RESULTS: Median time (IQR) for IT knife ESD was 43 minutes (range 36-50 minutes). The median time (IQR) for Maryland dissector ESD was 32 minutes (range 22-41 minutes; P = .09). The resection specimens obtained with the Maryland dissector tended to be larger, with a median (IQR) of 20.2 cm(2) (range 16.4-23 cm(2)) when compared with specimens resected with the IT knife, which yielded a median (IQR) resection area of 15.9 cm(2) (14.8-18.7 cm(2); P = .08). Complete en-bloc resection including all of the electrocautery markings was achieved in all cases. There were no perforations. There were two minor hemorrhages in the IT knife group and 3 in the Maryland dissector group. LIMITATIONS: Nonsurvival setting, small sample size. CONCLUSION: The flexible Maryland dissector was demonstrated to be efficient, safe, and feasible for facilitating gastric ESD in a live animal model. [ABSTRACT FROM AUTHOR]

Introduction: Endoscopic radiofrequency ablation (ERFA) is being evaluated as definitive treatment for patients with Barrett's esophagus (BE). Guidelines have yet to be developed for the application of this technology to patients with ultralong-segment BE (ULBE, > or = 8 cm). This study reports a single institution's experience with ERFA of ULBE.Methods: A retrospective review of patients with ULBE undergoing ERFA from August 2005 to February 2009 was conducted. The entire segment of intestinal metaplasia (IM) was treated at each session using balloon- and/or plate-based devices (BARRX Medical, Inc., Sunnyvale, CA). Retreatments, endoscopic mucosal resection (EMR), dilations, and biopsies were performed based on endoscopic findings. Surveillance was conducted according to standard guidelines.Results: Twenty-five patients (22 male) with a median age of 66 years [interquartile range (IQR) 57-74 years] were included. The length of BE treated was 10 cm (median; IQR 8-12 cm). Intramucosal carcinoma (IMC) was present in 3 patients, 15 had high-grade dysplasia (HGD), 6 had low-grade dysplasia (LGD), and 1 had IM without dysplasia. Complications for all 25 patients included hemorrhage (n = 1), stricture (n = 2), and nausea and vomiting (n = 2). Time from the initial procedure was such that 15 patients had postablation biopsies at least once. One patient with biopsies elected to undergo esophagectomy. Of these patients, 78.5% (11/14) had complete response (CR; no residual IM), two patients regressed from HGD to IM, and one patient with IMC had residual HGD and was treated with repeat EMR. The number of ablations in this group was 2.5 (median, IQR 2-3) during a median follow-up time of 20.3 months (IQR 10.4-29.2 months).Conclusion: ERFA is safe and feasible in patients with ULBE and can be applied to the entire length of IM during one session. Eradication of BE can be achieved with few repeat ablations and continued, vigilant surveillance. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Direct Drive Endoscopic System (DDES) is a multitasking platform developed to overcome the limitations of the currently available rigid and flexible endoscopic systems in application to natural orifice transluminal endoscopic surgery (NOTES), single-port laparoscopy, and advanced endoluminal procedures. The system consists of a 3-channel, steerable guide sheath accepting a 6-mm endoscope and two 4-mm articulating instruments. The system's overall design enables the interventionalist to operate instruments bimanually from a stable platform, conveying a laparoscopic paradigm to the functional working space at the distal end of the flexible guide sheath. OBJECTIVE: To assess the basic functionality of the DDES device in a series of defined exercises by using ex vivo porcine stomachs and 1 in vivo animal model. DESIGN: Ex vivo calibration and training exercises, including EMR, full-thickness suturing, and knot tying. SETTING: Animal laboratory. INTERVENTIONS: EMR, full-thickness suturing, and knot tying. MAIN OUTCOME MEASUREMENTS: Successful completion of specified tasks. RESULTS: Independent instrument movement with a wide range of motion allowed the interventionalist to perform several complex tasks efficiently. The DDES was able to (1) grasp tissue and hold it under tension, (2) cut through layers of porcine stomach in a controlled fashion, (3) suture, and (4) tie knots. LIMITATION: Ex vivo study. CONCLUSIONS: This novel multitasking platform demonstrated surgical functionality including triangulation, cutting, grasping, suturing, and knot tying. Preliminary results suggest that the DDES can perform complex endosurgical tasks that have traditionally been challenging or impossible with the standard endoscopic paradigm, and may enable NOTES, single-port laparoscopy, and complex endoluminal procedures. [ABSTRACT FROM AUTHOR]

BackgroundEndoscopic closure of inadvertent or intentional colon perforations might be valuable if comparable to surgical closure.ObjectiveThe aim of this study was to compare endoscopic closure of a 4-cm colon perforation in a porcine model with surgical closure in a multicenter study.SettingUniversity hospitals in the United States and Europe.Design and InterventionsAfter creating a 4-cm linear colon perforation, the animals were randomized to either endoscopic or surgical closure. The total procedure time from the beginning of perforation to the completion of procedure was measured. The animals were euthanized after 2 weeks to evaluate healing, unless there was a complication.ResultsFifty-four animals were randomized to either surgical or endoscopic closure of colon perforation. Eight animals developed complications, and 7 of these were euthanized before 2 weeks. Twenty-three animals in each group survived for 2 weeks. Surgical closure of the perforation was successful in all animals in that group, and endoscopic closure was successful in 25 of the 27 animals. The median procedure time was shorter in the surgery group compared to the endoscopy group (35 vs 44 minutes, P = .016). Peritonitis, local adhesions, and leak test results were comparable in both groups. Distant adhesions were less frequent in the endoscopic closure group (26.1% vs 56.5%, P = .03). Five of the 186 T-tags (2.7%) were noted in the adjacent viscera.LimitationThis porcine study does not mimic clean colon perforation in humans; it mimics dirty colon perforation in humans.ConclusionsEndoscopic closure of a 4-cm colon perforation was comparable to surgery, and this technique can be potentially used for closure of intentional or inadvertent colon perforations. [ABSTRACT FROM AUTHOR]

Context: Laboratory and epidemiological data suggest that folic acid may have an antineoplastic effect in the large intestine.Objective: To assess the safety and efficacy of folic acid supplementation for preventing colorectal adenomas.Design, Setting, and Participants: A double-blind, placebo-controlled, 2-factor, phase 3, randomized clinical trial conducted at 9 clinical centers between July 6, 1994, and October 1, 2004. Participants included 1021 men and women with a recent history of colorectal adenomas and no previous invasive large intestine carcinoma.Intervention: Participants were randomly assigned in a 1:1 ratio to receive 1 mg/d of folic acid (n = 516) or placebo (n = 505), and were separately randomized to receive aspirin (81 or 325 mg/d) or placebo. Follow-up consisted of 2 colonoscopic surveillance cycles (the first interval was at 3 years and the second at 3 or 5 years later).Main Outcome Measures: The primary outcome measure was occurrence of at least 1 colorectal adenoma. Secondary outcomes were the occurrence of advanced lesions (> or =25% villous features, high-grade dysplasia, size > or =1 cm, or invasive cancer) and adenoma multiplicity (0, 1-2, or > or =3 adenomas).Results: During the first 3 years, 987 participants (96.7%) underwent colonoscopic follow-up, and the incidence of at least 1 colorectal adenoma was 44.1% for folic acid (n = 221) and 42.4% for placebo (n = 206) (unadjusted risk ratio [RR], 1.04; 95% confidence interval [CI], 0.90-1.20; P = .58). Incidence of at least 1 advanced lesion was 11.4% for folic acid (n = 57) and 8.6% for placebo (n = 42) (unadjusted RR, 1.32; 95% CI, 0.90-1.92; P = .15). A total of 607 participants (59.5%) underwent a second follow-up, and the incidence of at least 1 colorectal adenoma was 41.9% for folic acid (n = 127) and 37.2% for placebo (n = 113) (unadjusted RR, 1.13; 95% CI, 0.93-1.37; P = .23); and incidence of at least 1 advanced lesion was 11.6% for folic acid (n = 35) and 6.9% for placebo (n = 21) (unadjusted RR, 1.67; 95% CI, 1.00-2.80; P = .05). Folic acid was associated with higher risks of having 3 or more adenomas and of noncolorectal cancers. There was no significant effect modification by sex, age, smoking, alcohol use, body mass index, baseline plasma folate, or aspirin allocation.Conclusions: Folic acid at 1 mg/d does not reduce colorectal adenoma risk. Further research is needed to investigate the possibility that folic acid supplementation might increase the risk of colorectal neoplasia.Trial Registration: clinicaltrials.gov Identifier: NCT00272324. [ABSTRACT FROM AUTHOR]

Esophageal cancer is frequently treated with esophagectomy, which is associated with distinct complications. Delayed gastric conduit emptying is a well-recognized complication that usually occurs within the postoperative period. By contrast, gastric tube volvulus is a rarer complication with a more variable time course of onset after esophagectomy and can be mistaken for delayed gastric conduit emptying. We describe the fifth reported case of gastric tube volvulus occurring years after esophagectomy and its successful treatment via endoscopic stenting., (© 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Anecdotal evidence suggests that pancreatic acinar metaplasia (PAM) and intestinal metaplasia (IM) overlap infrequently at the gastroesophageal junction/distal esophagus (GEJ/DE). The goal of this study was to evaluate the significance of PAM at GEJ/DE in relation to IM in patients with gastroesophageal reflux disease (GERD). Group 1 comprised 230 consecutive patients with GEJ/DE biopsies (80.6% with GERD symptoms). Group 2 comprised 151 patients with established GERD and GEJ/DE biopsies taken before Nissen fundoplication. Group 3 comprised 540 consecutive patients used for a follow-up study of PAM. PAM was present in 15.7%-15.9% and IM in 24.8%-31.1% of patients in groups 1 and 2, respectively. PAM-IM overlap was present in 2.2%-3.3%, respectively. Patients with PAM were, on average, 6-12 years younger than patients with IM, and were predominantly female (72.2%-75%), in contrast to patients with IM (47.3%-32%). In the unadjusted logistic regression model, patients with PAM were 69%-65% less likely to also have IM, as compared to patients without PAM. In the fully adjusted model, patients with PAM were 35%-61% less likely to also have IM, although the P-value was not significant. Follow-up analysis of patients with PAM from group 3 (n = 28) demonstrated the prevalence of IM and PAM in subsequent biopsies at 7.1% and 60.7%, respectively. No cases showed PAM-IM overlap on follow-up. The data suggests that PAM at the GEJ/DE is associated with protective effect against IM and thus could be useful as a marker of decreased susceptibility to IM., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Bariatric surgery is associated with weight loss attributed to reduced caloric intake, mechanical changes, and alterations in gut hormones. However, some studies have suggested a heightened incidence of colorectal cancer (CRC) has been associated with bariatric surgery, emphasizing the importance of identifying mechanisms of risk. The objective of this study was to determine if bariatric surgery is associated with decreases in fecal short-chain fatty acids (SCFA), a group of bacterial metabolites of fiber. Fecal samples ( n = 22) were collected pre- (~6 weeks) and post-bariatric surgery (~4 months) in patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy. SCFA levels were quantified using liquid chromatography/mass spectrometry. Dietary intake was quantified using 24-h dietary recalls. Using an aggregate variable, straight SCFAs significantly decreased by 27% from pre- to post-surgery, specifically acetate, propionate, butyrate, and valerate. Pre-surgery weight was inversely associated with butyrate, with no association remaining post-surgery. Multiple food groups were positively (sugars, milk, and red and orange vegetables) and inversely (animal protein) associated with SCFA levels. Our results suggest a potential mechanism linking dietary intake and SCFA levels with CRC risk post-bariatric surgery with implications for interventions to increase SCFA levels.

Introduction: Effective weight-management interventions require frequent interactions with specialised multidisciplinary teams of medical, nutritional and behavioural experts to enact behavioural change. However, barriers that exist in rural areas, such as transportation and a lack of specialised services, can prevent patients from receiving quality care., Methods: We recruited patients from the Dartmouth-Hitchcock Weight & Wellness Center into a single-arm, non-randomised study of a remotely delivered 16-week evidence-based healthy lifestyle programme. Every 4 weeks, participants completed surveys that included their willingness to pay for services like those experienced in the intervention. A two-item Willingness-to-Pay survey was administered to participants asking about their willingness to trade their face-to-face visits for videoconference visits based on commute and copay., Results: Overall, those with a travel duration of 31-45 min had a greater willingness to trade in-person visits for telehealth than any other group. Participants who had a travel duration less than 15 min, 16-30 min and 46-60 min experienced a positive trend in willingness to have telehealth visits until Week 8, where there was a general negative trend in willingness to trade in-person visits for virtual. Participants believed that telemedicine was useful and helpful., Conclusions: In rural areas where patients travel 30-45 min a telemedicine-delivered, intensive weight-loss intervention may be a well-received and cost-effective way for both patients and the clinical care team to connect.

Background/objectives: Obesity is a pressing health concern within the United States (US). Obesity medicine "diplomates" receive specialized training, yet it is unclear if their accessibility and availability adequately serves the need. The purpose of this research was to understand how accessibility has evolved over time and assess the practicality of serving an estimated patient population with the current distribution and quantity of diplomates., Methods: Population-weighted Census tracts in US counties were mapped to the nearest facility on a road network with at least one diplomate who specialized in adult (including geriatric) care between 2011 and 2019. The median travel time for all Census tracts within a county represented the primary geographic access measure. Availability was assessed by estimating the number of diplomates per 100 000 patients with obesity and the number of facilities able to serve assigned patients under three clinical guidelines., Results: Of the 3371 diplomates certified since 2019, 3036 were included. The median travel time (weighted for county population) fell from 28.5 min [IQR: 13.7, 68.1] in 2011 to 9.95 min [IQR: 7.49, 18.1] in 2019. There were distinct intra- and inter-year travel time variations by race, ethnicity, education, median household income, rurality, and Census region (all P < 0.001). The median number of diplomates per 100 000 with obesity grew from 1 [IQR: 0.39, 1.59] in 2011 to 5 [IQR: 2.74, 11.4] in 2019. In 2019, an estimated 1.7% of facilities could meet the recommended number of visits for all mapped patients with obesity, up from 0% in 2011., Conclusions: Diplomate geographic access and availability have improved over time, yet there is still not a high enough supply to serve the potential patient demand. Future studies should quantify patient-level associations between travel time and health outcomes, including whether the number of available diplomates impacts utilization., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Context.—: Published reports have suggested an association of lymphocytic esophagitis (LyE) with gastroesophageal reflux disease (GERD) and primary motility disorders and have also shown that GERD and motility disorders frequently overlap. These findings make it difficult to determine the true relationship between LyE and GERD, which may be confounded by the presence of motility disorders with LyE., Objective.—: To characterize patterns of lymphocytic inflammation in patients with GERD who have no motility abnormalities., Design.—: We identified 161 patients seen at our institution from 1998 to 2014 who were diagnosed with GERD, had normal esophageal motility, and available esophageal biopsies. LyE was defined as peripapillary lymphocytosis with rare or absent granulocytes. CD4 and CD8 immunophenotype of lymphocytes was evaluated using immunohistochemistry., Results.—: We found increased intraepithelial lymphocytes in 13.7% of patients with GERD. Two major patterns and 1 minor pattern of lymphocytic inflammation were observed as follows: (1) LyE (in 6.8% [11 of 161] of patients and typically focal), (2) dispersed lymphocytes in an area of reflux esophagitis (in 5.6% [9 of 161] and typically diffuse), and (3) peripapillary lymphocytes in an area of reflux esophagitis (in 1.2% [2 of 161]). CD8 T cells significantly outnumbered CD4 T cells in 91% of patients with lymphocytic esophagitis and 100% of patients with dispersed lymphocytes (9 of 9) or peripapillary lymphocytes (2 of 2) in the area of reflux esophagitis., Conclusions.—: These findings suggest that LyE is one of the major patterns of lymphocytic inflammation in GERD. CD8 T-cell-predominant immunophenotype may be useful as a marker of GERD in the differential diagnosis of LyE.

Purpose: Few evidence-based strategies are specifically tailored for disparity populations such as rural adults. Two-way video-conferencing using telemedicine can potentially surmount geographic barriers that impede participation in high-intensity treatment programs offering frequent visits to clinic facilities. We aimed to understand barriers and facilitators of implementing a telemedicine-delivered tertiary-care, rural academic weight-loss program for the management of obesity., Methods: A single-arm study of a 16-week, weight-loss pilot evaluated barriers and facilitators to program participation and exploratory measures of program adoption and staff confidence in implementation and intervention delivery. A program was delivered using video-conferencing within an existing clinical infrastructure. Elements of Consolidated Framework for Implementation Research (CFIR) provided a basis for assessing intervention characteristics, inner and outer settings, and individual characteristics using surveys and semi-structured interviews. We evaluated elements of the RE-AIM model (reach, adoption) to assess staff barriers to success for future scalability., Findings: There were 27 patients and 8 staff completing measures. Using CFIR, the intervention was valuable from a patient participant standpoint; staff equally had positive feelings about using telemedicine as useful for patient care. The RE-AIM framework demonstrated limited reach but willingness to adopt was above average. A significant barrier limiting sustainability was physical space for intervention delivery and privacy and dedicated resources for staff. Scheduling stressors were also a challenge in its implementation., Conclusions: The need to engage staff, enhance organizational culture, and increase reach are major factors for rural health obesity clinics to enhance sustainability of using telemedicine for the management of obesity., Trial Registration: Clinicaltrials.gov NCT03309787. Registered on 16 October 2017., Competing Interests: Competing interestsThere are no competing interests. There are no conflicts of interest pertaining to this manuscript., (© The Author(s) 2020.)

Background: The public health crisis of obesity leads to increasing morbidity that are even more profound in certain populations such as rural adults. Live, two-way video-conferencing is a modality that can potentially surmount geographic barriers and staffing shortages., Methods: Patients from the Dartmouth-Hitchcock Weight and Wellness Center were recruited into a pragmatic, single-arm, nonrandomized study of a remotely delivered 16-week evidence-based healthy lifestyle programme. Patients were provided hardware and appropriate software allowing for remote participation in all sessions, outside of the clinic setting. Our primary outcomes were feasibility and acceptability of the telemedicine intervention, as well as potential effectiveness on anthropometric and functional measures., Results: Of 62 participants approached, we enrolled 37, of which 27 completed at least 75% of the 16-week programme sessions (27% attrition). Mean age was 46.9 ± 11.6 years (88.9% female), with a mean body mass index of 41.3 ± 7.1 kg/m 2 and mean waist circumference of 120.7 ± 16.8 cm. Mean patient participant satisfaction regarding the telemedicine approach was favourable (4.48 ± 0.58 on 1-5 Likert scale-low to high) and 67.6/75 on standardized questionnaire. Mean weight loss at 16 weeks was 2.22 ± 3.18 kg representing a 2.1% change ( P < .001), with a loss in waist circumference of 3.4% ( P = .001). Fat mass and visceral fat were significantly lower at 16 weeks (2.9% and 12.5%; both P < .05), with marginal improvement in appendicular skeletal muscle mass (1.7%). In the 30-second sit-to-stand test, a mean improvement of 2.46 stands ( P = .005) was observed., Conclusion: A telemedicine-delivered, intensive weight loss intervention is feasible, acceptable, and potentially effective in rural adults seeking weight loss., Competing Interests: There are no conflicts of interest pertaining to this manuscript., (© 2019 The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd.)

Sarcopenic obesity portends poor outcomes, yet it is under-recognized in practice. We collected baseline clinical data including data on body composition (total and segmental muscle mass and total body fat), grip strength, and 5-times sit-to-stand. We defined sarcopenia using cut-points for appendicular lean mass (ALM) and obesity using body-fat cut-points. A total of 599 clinic patients (78.5% female; mean age was 51.3 ± 14.2 years) had bioelectrical impedance analysis (BIA) data (83.8%). Mean body mass index (BMI) and waist circumference were 43.1 ± 8.9 kg/m 2 and 132.3 ± 70.7 cm, respectively. All patients had elevated body fat. There were 284 (47.4%) individuals fulfilling criteria for ALM-defined sarcopenia. Sarcopenic obese persons had a lower BMI (38.2 ± 6.4 vs 47.6 ± 8.6; P  < 0.001), fat-free mass (113.0 kg ± 16.1 vs 152.1 kg ± 29.4; P  < 0.001), fat mass (48.4% ± 5.9 vs 49.5% ± 6.2; P  = 0.03), and visceral adipose tissue (216.8 ± 106.3 vs 242.7 ± 133.6 cm 3 ; P  = 0.009) than those without sarcopenic obesity. Grip strength was lower in those with sarcopenic obesity (25.1 ± 8.0 vs 30.5 ± 11.3 kg; P  < 0.001) and sit-to-stand times were longer (12.4 ± 4.4 vs 10.8 second ± 4.6; P  = 0.03). Sarcopenic obesity was highly prevalent in a rural, tertiary care weight and wellness center., Competing Interests: Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background and Aims: Barrett's intestinal metaplasia may extend beneath normal squamous epithelium at the squamocolumnar junction (SCJ) and therefore escape surveillance biopsy sampling. The prevalence of subsquamous intestinal metaplasia (SSIM) in patients undergoing Barrett's esophagus (BE) surveillance is unknown. Our aim was to examine the prevalence and distribution of SSIM proximal to the SCJ in patients undergoing BE surveillance., Methods: We enrolled consecutive patients with biopsy specimen-proven BE. Biopsy specimens were obtained from the squamous epithelium at 5 mm and 10 mm above the SCJ. The primary outcomes were the proportion of patients with SSIM at each level. We further assessed factors associated with SSIM., Results: We examined 515 squamous epithelial biopsy specimens from 106 BE patients (95% men; mean age, 66 years) with a mean Barrett's length of 3.0 cm. SSIM was present in 39% at 5 mm (95% CI, 29.4-48.6) and 21% (95% CI, 11.7-32.1) at 10 mm proximal to the SCJ. Among all biopsy specimens, 13% (95% CI, 10.6-16.6) contained SSIM: 17% (95% CI, 13-21.6) of biopsy samples at 5 mm and 8% (95% CI, 4.3-12.2) at 10 mm proximal to the SCJ. SSIM was more common in the anterior/right lateral position compared with the posterior/left lateral position (21% vs 11%, P = .001). None of the biopsy specimens showed dysplasia. Length of BE or duration of reflux symptoms were not associated with the presence of SSIM., Conclusions: This cross-sectional study found a surprisingly high proportion of SSIM in treatment-naïve patients proximal to the SCJ. These findings raise questions regarding BE management and the prevalence of SSIM in normal-appearing esophagus., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: Roux-en-Y gastric bypass (RYGB) surgery is an established modality for the treatment of morbid obesity. However, approximately one-quarter of patients experience weight regain after initially successful weight loss. Endoscopic therapy targeting the gastric remnant pouch represents a novel potential strategy to re-induce weight loss in this population. We performed a pilot trial of radiofrequency ablation (RFA) of the gastric remnant pouch after RYGB to determine feasibility, safety, and efficacy for weight loss., Methods: We identified patients who had undergone RYGB, achieved >40% excess body weight loss (EBWL), and then regained >25% of lost weight. RFA was applied to the gastrojejunal anastomosis and the entire surface area of the gastric remnant pouch. Treatment was repeated at 4 and 8 months if patients did not meet specified weight loss targets. Weekly weights were obtained for 12 months. The primary efficacy outcome was percent EBWL at 12 months, compared with baseline., Results: Twenty-five patients were enrolled at 4 centers. Mean (± standard deviation [SD]) age was 45.4 ± 9.1 years, and 84% (21/25) were female. Mean (± SD) baseline body mass index was 40.2 ± 7.8. Twenty-two of 25 patients completed 12 months of follow-up. At 12 months, median (± SD) EBWL was 18.4% (interquartile ratio 10.8, 33.7; P < .0001). Significant weight loss was seen at 3.5 months (P < .0001) and at 7.5 months (P < .0001), with a significant trend for continued weight loss over the 12-month period (P = .013). Two patients had serious adverse events requiring hospitalization., Conclusions: RFA of the gastric remnant pouch in patients with weight regain after RYGB resulted in significant reductions in excess body weight with an acceptable safety profile. Continued weight loss was observed after each RFA treatment. Further clinical trials in well-selected populations are warranted to determine the optimal number and frequency of RFA treatments and to assess durability of weight loss. (Clinical trial registration number: NCT01910688.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

This article focuses on the stomach target devices that are currently in various stages of development. Approved intragastric balloons, devices targeting small bowel and aspiration techniques, are described in other contributions to this issue. Bariatric endoscopic devices targeting the stomach directly alter gastric physiology and promote weight loss by potentially changing functional gastric volume, gastric emptying, gastric wall compliance, neurohormonal signaling, and, thereby, satiety. Many stomach-targeting devices are on the horizon for clinical use, and further study will determine the safety and efficacy for clinical use., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background and Aims: The aim of the study was to identify endoscopist-related and procedural factors that may be associated with the quality of optical diagnosis of diminutive polyps using narrow-band imaging (NBI)., Methods: All subjects who participated in a randomized trial on cap-assisted colonoscopy were eligible for the current study. Optical polyp diagnosis was an a priori outcome of the initial trial. Ten participating endoscopists used NBI to assess all of the diagnosed polyps as adenomatous or non-adenomatous in real-time and provided a degree of diagnostic certainty. The main outcome measures were quality benchmarks of optical diagnosis (negative predictive value [NPV] for diminutive rectosigmoid adenomas, agreement with pathology-based surveillance interval) and assessment of endoscopist-related and procedural factors potentially associated with the quality of optical diagnosis., Results: A total of 1650 polyps were found in 607 patients, with 1311 polyps (79 %) being diminutive, of which 672 (53 %) were adenomatous. The NPV of optical diagnosis for rectosigmoid adenomas was 95 %. The optical diagnosis-based surveillance interval agreed with the pathology-based recommendation in 93 % of patients. Prior experience with image-enhanced endoscopy had no effect on optical diagnosis. Low and high adenoma detectors were not different in achieving the quality benchmarks. Cap-assisted colonoscopy was not associated with quality of optical diagnosis. Quality metrics of optical diagnosis remained similar during the first and second half of the study period., Conclusion: High quality optical diagnosis of diminutive polyps can be achieved and sustained by endoscopists previously inexperienced in this practice with minimal training. None of the examined factors appear to affect the quality of optical diagnosis; particularly, endoscopists' adenoma detection was not associated with optical diagnosis., (© Georg Thieme Verlag KG Stuttgart · New York.)

The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.

Radiofrequency ablation (RFA), with or without endoscopic mucosal resection (EMR), is a safe, effective, and durable treatment option for Barrett esophagus (BE)-associated dysplasia (DYS), but few studies have identified predictors of treatment failure in BE-associated intramucosal adenocarcinoma (IMC). The aim of this study was to determine the rate of IMC eradication when using RFA±EMR and to identify clinical and pathologic predictors of treatment failure. A retrospective review of medical records and a central review of index histologic parameters were performed for 78 patients who underwent RFA±EMR as the primary treatment for biopsy-proven IMC at 4 academic tertiary medical centers. Complete eradication (CE) (absence of IMC/DYS on first follow-up endoscopy) was achieved in 86% of patients, and durable eradication (DE) (CE with no recurrence of IMC/DYS until last follow-up) was achieved in 78% of patients, with significant variation between the 4 study sites (P=0.03 and 0.09 by analysis of variance for DE and CE, respectively). Use of EMR before RFA significantly reduced the risk for treatment failure for IMC/DYS (hazard ratio, 0.15; 95% confidence interval, 0.05-0.48; P=0.001), whereas IMC involving ≥50% of the columnar metaplastic area on index examination significantly increased the risk for treatment failure (hazard ratio, 4.24; 95% confidence interval, 1.53-11.7; P=0.005). Endoscopic and pathologic factors associated with treatment failure in BE-associated IMC treated with RFA±EMR may help identify the subset of IMC patients for whom a more aggressive initial approach may be justified.

Biliary stenting is clinically effective in relieving both malignant and non-malignant obstructions. However, there are high failure rates associated with tumor ingrowth and epithelial overgrowth as well as internally from biofilm development and subsequent clogging. Within the last decade, the use of prophylactic drug eluting stents as a means to reduce stent failure has been investigated. In this review we provide an overview of the current research on drug eluting biliary stents. While there is limited human trial data regarding the clinical benefit of drug eluting biliary stents in preventing stent obstruction, recent research suggests promise regarding their safety and potential efficacy.

Background & Aims: Radiofrequency ablation (RFA) is commonly used to treat Barrett's esophagus (BE). We assessed the incidence of esophageal adenocarcinoma (EAC) after RFA, factors associated with the development of EAC, and EAC-specific and all-cause mortality., Methods: We collected data for outcomes of patients who underwent RFA for BE from July 2007 through July 2011 from US multicenter RFA Patient Registry. Patients were followed until July 2014. Kaplan-Meier curves of EAC incidence were stratified by baseline histology. Crude EAC incidence and mortality (all-cause and EAC-specific) were calculated, and adjusted all-cause mortality was assessed. Logistic regression models were constructed to assess predictors of EAC and all-cause mortality., Results: Among 4982 patients, 100 (2%) developed EAC (7.8/1000 person-years [PY]) and 9 patients (0.2%) died of EAC (0.7/1000 PY) in a mean 2.7 ± 1.6 years. The incidence of EAC in nondysplastic BE was 0.5/1000 PY. Overall, 157 patients (3%) died during follow-up (all-cause mortality, 11.2/1000 PY). On multivariate logistic regression, baseline BE length (odds ratio, 1.1/ cm) and baseline histology (odds ratios, 5.8 and 50.3 for low-grade dysplasia and high-grade dysplasia [HGD] respectively) predicted EAC incidence. Among 9 EAC deaths, 6 (67%) had baseline HGD, and 3 (33%) had baseline intramucosal EAC. The most common causes of death were cardiovascular (15%) and extraesophageal cancers (15%). No deaths were associated with RFA., Conclusions: Based on analysis of a multicenter registry of patients who underwent RFA of BE, less than 1% died from EAC. The incidence of EAC was markedly lower in this study than in other studies of disease progression, with the greatest absolute benefit observed in patients with HGD., (Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Study Aim: Cap-assisted colonoscopy has improved adenoma detection in some but not other studies. Most previous studies have been limited by small sample sizes and few participating endoscopists. The aim of the current study was to evaluate whether cap-assisted colonoscopy improves adenoma detection in a two-center, multi-endoscopist, randomized trial., Patients and Methods: Consecutive patients who presented for an elective colonoscopy were randomized to cap-assisted colonoscopy (4-mm cap) or standard colonoscopy performed by one of 10 experienced endoscopists. Primary outcome measures were mean number of adenomas per patient and adenoma detection rate (ADR). Secondary outcomes included procedural measures and endoscopist variation; a logistic regression model was employed to examine predictors of increased detection with cap use., Results: A total of 1113 patients (64 % male, mean age 62 years) were randomized to cap-assisted (n = 561) or standard (n = 552) colonoscopy. The mean number of adenomas detected per patient in the cap-assisted and standard groups was similar (0.89 vs. 0.82; P = 0.432), as was the ADR (42 % vs. 40 %; P = 0.452). Cap-assisted colonoscopy achieved a faster cecal intubation time (4.9 vs. 5.8 minutes; P < 0.001), a similar cecal intubation rate (99 % vs. 98 %; P = 0.326), and a higher terminal ileum intubation rate (93 % vs. 89 %; P < 0.028). Cap-assisted colonoscopy resulted in a 20 % increase in ADR for some endoscopists and in a 15 % decrease for others. Individual preference for the cap was an independent predictor of increased adenoma detection in adjusted analysis (P < 0.001), whereas baseline low adenoma detection was not., Conclusion: Although the efficiency of cecal and terminal ileum intubation was slightly improved by cap-assisted colonoscopy, adenoma detection was not. Cap-assisted colonoscopy may be beneficial for selected endoscopists., Trial Registration: clinicalTrials.gov (NCT01935180)., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Little is known about differences in Barrett's esophagus (BE) characteristics by sex and race and/or ethnicity or these differences in response to radiofrequency ablation (RFA)., Objective: We compared disease-specific characteristics, treatment efficacy, and safety outcomes by sex and race and/or ethnicity in patients treated with RFA for BE., Design: The U.S. RFA patient registry is a multicenter collaboration reporting processes and outcomes of care for patients treated with RFA for BE., Patients: Patients enrolled with BE., Interventions: RFA., Main Outcome Measurements: We assessed safety (stricture, bleeding, perforation, hospitalization), efficacy (complete eradication of intestinal metaplasia [CEIM]), complete eradication of dysplasia, and number of treatments to CEIM by sex and race and/or ethnicity., Results: Among 5521 patients (4052 men; 5126 white, 137 Hispanic, 82 African American, 40 Asian, 136 heritage not identified), women were younger (60.0 vs 62.1 years) and had shorter BE segments (3.2 vs 4.4 cm) and less dysplasia (37% vs 57%) than did men. Women were almost twice as likely to stricture (odds ratio 1.7; 95% confidence interval, 1.2-2.3). Although white patients were predominantly male, about half of African Americans and Asians with BE were female. African Americans and Asians had less dysplasia than white patients. Asians and African Americans had more strictures than did white patients. There were no sex or race differences in efficacy., Limitations: Observational study with non-mandated paradigms, no central laboratory for reinterpretation of pathology., Conclusion: In the U.S. RFA patient registry, women had shorter BE segments and less-aggressive histology. The usual tendency toward BE in men was absent in African Americans and Asians. Posttreatment stricture was more common among women and Asians. RFA efficacy did not differ by sex or race., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Radiofrequency ablation (RFA), with or without endoscopic mucosal resection (EMR), has been validated as a safe, effective and durable treatment option for dysplastic Barrett's esophagus. Its durability in eradicating Barrett's-associated intramucosal carcinoma (IMC), however, is unclear. We set out to assess the long-term safety and efficacy of RFA for IMC., Methods: Retrospective review of two tertiary care facility records for patients undergoing RFA, with or without EMR, for biopsy-proven IMC. Our primary outcome of interest was to quantify the rate of durable complete eradication for intestinal metaplasia and for IMC and associated dysplasia. A multi-variate regression analysis was performed to identify features which correlate with durable eradication of IMC/dysplasia. Our secondary outcome of interest was treatment-related complications., Results: 36 patients (26 male; mean age 64 ± 12 years), with a mean Barrett's length of 3.5 ± 2.5 cm, underwent RFA for biopsy-proven IMC. EMR was performed in 31 (86%) prior to or during RFA. Complete eradication of IMC/dysplasia was achieved in 32/36 (89%) and patients required a mean of 1 ± 1 EMR and 2 ± 1 RFA sessions to achieve eradication. During a mean follow-up period of 24 ± 19 months, durable complete eradication of IMC/dysplasia was achieved in 29/36 (81%) patients. On multi-variate regression analysis, undergoing an EMR prior to RFA was associated with an increased likelihood of maintaining durable eradication of IMC/dysplasia (p = 0.03). Treatment-related complications included: bleeding (3%) and stricture formation (19%)., Conclusion: RFA is an effective and durable treatment option for Barrett's-associated IMC. Greater than 80% of patients will achieve and maintain complete eradication of IMC at a mean of 2 years follow-up.

Background & Aims: After radiofrequency ablation (RFA), patients may experience recurrence of Barrett's esophagus (BE) after complete eradication of intestinal metaplasia (CEIM). Rates and predictors of recurrence after successful eradication have been poorly described., Methods: We used the US RFA Registry, a nationwide registry of BE patients receiving RFA, to determine rates and factors that predicted recurrence of intestinal metaplasia (IM). We assessed recurrence by Kaplan-Meier analysis for the overall cohort and by worst pretreatment histology. Characteristics associated with recurrence were included in a logistic regression model to identify independent predictors., Results: Among 5521 patients, 3728 had biopsies 12 months or more after initiation of RFA. Of these, 3169 (85%) achieved CEIM, and 1634 (30%) met inclusion criteria. The average follow-up period was 2.4 years after CEIM. IM recurred in 334 (20%) and was nondysplastic or indefinite for dysplasia in 86% (287 of 334); the average length of recurrent BE was 0.6 cm. In Kaplan-Meier analysis, more advanced pretreatment histology was associated with an increased yearly recurrence rate. Compared with patients without recurrence, patients with recurrence were more likely, based on bivariate analysis, to be older, have longer BE segments, be non-Caucasian, have dysplastic BE before treatment, and require more treatment sessions. In multivariate analysis, the likelihood for recurrence was associated with increasing age and BE length, and non-Caucasian race., Conclusions: BE recurred in 20% of patients followed up for an average of 2.4 years after CEIM. Most recurrences were short segments and were nondysplastic or indefinite for dysplasia. Older age, non-Caucasian race, and increasing length of BE length were all risk factors. These risk factors should be considered when planning post-RFA surveillance intervals., (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe)., Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed., Results: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events., Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: The safety, efficacy, and durability of radiofrequency ablation (RFA), with or without EMR, have been established for long-segment Barrett's esophagus (LSBE). Ablating ultralong-segment Barrett's esophagus (ULSBE) may be associated with increased stricture formation, eradication failure, and treatment session requirements., Objectives: Our primary objective was to compare eradication and stricture rates between LSBE (≥3 to <8 cm) and ULSBE (≥8 cm). Our secondary objective was to evaluate treatment durability and session requirements., Design: Retrospective review of prospectively collected data., Setting: Tertiary care facility., Patients: A total of 72 patients (34 ULSBE, 38 LSBE; mean Barrett's segment length of 10.8 and 4.7 cm) underwent RFA between August 2005 and September 2010. Mean follow-up was 45 and 34 months, respectively., Main Outcome Measurements: Eradication and complication rates for ULSBE and LSBE., Results: Eradication rates for dysplasia (90% vs 88%, P = 1.0) and intestinal metaplasia (IM) (77% vs 82%, P = .77) were similar. ULSBE patients required more overall (P < .01) and circumferential (P < .01) RFA; however, stricture rates were identical (14%). There was no dysplasia recurrence, and IM recurrence was similar (ULSBE, 23%; LSBE, 16%; P = .52). At 3 years, IM remained eradicated in 65% of ULSBE and 82% of LSBE, without maintenance RFA. On multivariate regression analysis, increasing Barrett's length was associated with a reduced likelihood for eradicating IM (odds ratio 0.87; 95% CI, 0.75-1.00), but not dysplasia (odds ratio 1.13; 95% CI, 0.95-1.35)., Limitations: Single center., Conclusion: ULSBE can be treated in its entirety at each session with efficacy and safety comparable to LSBE. ULSBE requires more effort to achieve IM eradication, and RFA is less durable in maintaining this eradication at 3-year follow-up., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Gastroesophageal reflux disease (GERD) is a common entity in the United States. Surgical fundoplication can be performed safely with well-established long-term results. In selected patients with GERD, endoluminal therapy has a potential role. We report on a patient with recurrent GERD after two prior fundoplications who wished to pursue endoscopic treatment. The presence of a gastrostomy tube allowed for the performance of a transgastric-assisted endoluminal fundoplication using the EndoCinch (TM) device and standard pediatric laparoscopic instruments. Symptomatic relief of GERD with EndoCinch (TM) is common but the long-term outcomes are limited. Nevertheless, the EndoCinch (TM) device remains a method for endoscopic suturing in certain settings. In patients with gastrostomy access, the use of laparoscopic instruments may further enable the performance of advanced endoscopic therapies.

Background & Aims: Although the adenoma detection rate is used as a measure of colonoscopy quality, there are limited data on the quality of endoscopic resection of detected adenomas. We determined the rate of incompletely resected neoplastic polyps in clinical practice., Methods: We performed a prospective study on 1427 patients who underwent colonoscopy at 2 medical centers and had at least 1 nonpedunculated polyp (5-20 mm). After polyp removal was considered complete macroscopically, biopsies were obtained from the resection margin. The main outcome was the percentage of incompletely resected neoplastic polyps (incomplete resection rate [IRR]) determined by the presence of neoplastic tissue in post-polypectomy biopsies. Associations between IRR and polyp size, morphology, histology, and endoscopist were assessed by regression analysis., Results: Of 346 neoplastic polyps (269 patients; 84.0% men; mean age, 63.4 years) removed by 11 gastroenterologists, 10.1% were incompletely resected. IRR increased with polyp size and was significantly higher for large (10-20 mm) than small (5-9 mm) neoplastic polyps (17.3% vs 6.8%; relative risk = 2.1), and for sessile serrated adenomas/polyps than for conventional adenomas (31.0% vs 7.2%; relative risk = 3.7). The IRR for endoscopists with at least 20 polypectomies ranged from 6.5% to 22.7%; there was a 3.4-fold difference between the highest and lowest IRR after adjusting for size and sessile serrated histology., Conclusions: Neoplastic polyps are often incompletely resected, and the rate of incomplete resection varies broadly among endoscopists. Incomplete resection might contribute to the development of colon cancers after colonoscopy (interval cancers). Efforts are needed to ensure complete resection, especially of larger lesions. ClinicalTrials.gov Number: NCT01224444., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Ongoing gastroesophageal reflux may impair healing and re-epithelialization after radiofrequency ablation (RFA) of Barrett's esophagus (BE). Because prior fundoplication may improve reflux control, our aim was to assess the relationship between prior fundoplication and the safety/efficacy of RFA., Methods: We assessed the U.S. RFA Registry, a nationwide registry of BE patients receiving RFA at 148 institutions, to compare the safety and efficacy of ablation between those with prior fundoplication and those with medical management (proton pump inhibition)., Results: Among 5,537 patients receiving RFA, 301 (5.4 %) had prior fundoplication. Of fundoplication subjects, 1.0 % developed stricture and 1.0 % were hospitalized after RFA. Rates of stricture, bleeding, and hospitalization were not statistically different (p = ns) between patients with and without prior fundoplication. Complete eradication of intestinal metaplasia and complete eradication of dysplasia were achieved in 71 % and 87 % of fundoplication patients, and 73 % and 87 % of patients without fundoplication, respectively (p = ns for both). Patients with prior fundoplication needed similar numbers of RFA sessions for eradication compared with those without fundoplication., Conclusions: Radiofrequency ablation, with or without prior fundoplication, is safe and effective in eradicating BE. Prior fundoplication was associated with similar adverse event and efficacy rates when compared with medical management.

Purpose of Review: The increasing complexity of intralumenal and emerging translumenal endoscopic procedures has created an opportunity to apply robotics in endoscopy. Computer-assisted or direct-drive robotic technology allows the triangulation of flexible tools through telemanipulation. The creation of new flexible operative platforms, along with other emerging technology such as nanobots and steerable capsules, can be transformational for endoscopic procedures. In this review, we cover some background information on the use of robotics in surgery and endoscopy, and review the emerging literature on platforms, capsules, and mini-robotic units., Recent Findings: The development of techniques in advanced intralumenal endoscopy (endoscopic mucosal resection and endoscopic submucosal dissection) and translumenal endoscopic procedures (NOTES) has generated a number of novel platforms, flexible tools, and devices that can apply robotic principles to endoscopy. The development of a fully flexible endoscopic surgical toolkit will enable increasingly advanced procedures to be performed through natural orifices., Summary: The application of platforms and new flexible tools to the areas of advanced endoscopy and NOTES heralds the opportunity to employ useful robotic technology. Following the examples of the utility of robotics from the field of laparoscopic surgery, we can anticipate the emerging role of robotic technology in endoscopy.

Aim: To determine which patients might benefit most from retrograde viewing during colonoscopy through subset analysis of randomized, controlled trial data., Methods: The Third Eye® Retroscope® Randomized Clinical Evaluation (TERRACE) was a randomized, controlled, multicenter trial designed to evaluate the efficacy of a retrograde-viewing auxiliary imaging device that is used during colonoscopy to provide a second video image which allows viewing of areas on the proximal aspect of haustral folds and flexures that are difficult to see with the colonoscope's forward view. We performed a post-hoc analysis of the TERRACE data to determine whether certain subsets of the patient population would gain more benefit than others from use of the device. Subjects were patients scheduled for colonoscopy for screening, surveillance or diagnostic workup, and each underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC), randomized to SC followed by TEC or vice versa., Results: Indication for colonoscopy was screening in 176/345 subjects (51.0%), surveillance after previous polypectomy in 87 (25.2%) and diagnostic workup in 82 (23.8%). In 4 subjects no indication was specified. Previously reported overall results had shown a net additional adenoma detection rate (ADR) with TEC of 23.2% compared to SC. Relative risk (RR) of missing adenomas with SC vs TEC as the initial procedure was 1.92 (P = 0.029). Post-hoc subset analysis shows additional ADRs for TEC compared to SC were 4.4% for screening, 35.7% for surveillance, 55.4% for diagnostic and 40.7% for surveillance and diagnostic combined. The RR of missing adenomas with SC vs TEC was 1.11 (P = 0.815) for screening, 3.15 (P = 0.014) for surveillance, 8.64 (P = 0.039) for diagnostic and 3.34 (P = 0.003) for surveillance and diagnostic combined. Although a multivariate Poisson regression suggested gender as a possibly significant factor, subset analysis showed that the difference between genders was not statistically significant. Age, bowel prep quality and withdrawal time did not significantly affect the RR of missing adenomas with SC vs TEC. Mean sizes of adenomas detected with TEC and SC were similar at 0.59 cm and 0.56 cm, respectively (P = NS)., Conclusion: TEC allows detection of significantly more adenomas compared to SC in patients undergoing surveillance or diagnostic workup, but not in screening patients (ClinicalTrials.gov Identifier: NCT01044732).

Background: Devices used for flexible intralumenal procedures are inadequate when used for intraperitoneal surgical procedures such as cholecystectomy., Objective: To assess/address limitations of flexible endoscopic devices in intraperitoneal surgery., Design: To describe processes used to invent new devices to facilitate this new surgical genre., Setting: Engineering laboratory., Patients: None. INTERVENTIONS AND INVENTIONS: Reviews of the limitations of flexible endoscopic instruments and instrumentation/invention needs for a "NOTES cholecystectomy" were completed., Main Outcome Measures: The appropriateness of existing methods of device innovation was evaluated against an inventory of new technologies necessary to perform NOTES. The deficiencies in traditional innovation methods led to the creation of a novel process for invention of new medical devices: the "Inventorama.", Methods: Cooperation between clinicians and industry to develop device concepts to enable NOTES., Results: The devices included: (1) steerable flex trocar, (2) rotary access needle, (3) bipolar hemostasis forceps, (4) Maryland dissectors, (5) articulating hook knife, (6) rotating hook knife, (7) articulating graspers, (8) scissors, (9) ligating clip applier, and (10) tissue apposition system. Six of these ten were built and tested as initial crude prototypes in the Inventorama process; two underwent major modifications. Three were invented via alternate methods, including by independent clinicians., Conclusions: A new method for efficient medical device invention and development was created to address key technology needs for NOTES. The result was a "toolbox" of devices designed to address the key surgical activities necessary for advanced intralumenal and translumenal flexible endoscopic procedures.

Background: Endoscopic submucosal dissection (ESD) is increasingly used for en bloc removal of GI lesions. Current ESD techniques have limitations including long procedure times, technical difficulty, and complications., Objective: To compare mesna with saline solution for ESD., Design: Blinded, randomized, controlled, porcine study in live animals., Setting: Animal laboratory., Intervention: Twelve gastric lesions were marked by using electrocautery. After submucosal injection, a circumferential mucosal incision was created, and ESD was performed by using a flexible Maryland dissector. Half of the ESDs were performed with submucosal injection of mesna., Main Outcome Measurements: Primary outcome was the time to dissect the submucosal plane. Secondary outcomes were total ESD time, specimen size, and procedure related complications., Results: The average (± SD) time for dissecting the submucosal plane was 15 minutes (range 10-22 ± 4.8 min) in the group with submucosal mesna injection and 16 minutes (range 8-29 ± 8.3 min) in the control group (P = 1.0). Complete en bloc resection including all of the electrocautery markings was achieved in all cases. Injection of mesna did not provide any benefit over saline solution in terms of overall ESD time (24 ± 7.3 min vs 28 ± 11 min; P = .42). There were no perforations. Four hemorrhages requiring intervention were encountered during the procedures in the control group, compared with no bleeding in the mesna group (P = .09)., Limitations: Animal model, limited sample size., Conclusion: Submucosal mesna injection did not affect procedure times but was associated with a trend toward a lower incidence of intraprocedural bleeding., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

The following on endoscopic treatments of Barrett's esophagus includes commentaries on indications for endoscopic treatments; endo-luminal plication procedures; the cellular modifications induced by the endoscopic ablation therapies; eradication by banding without resection; the evaluation of complete ablation; recurrence after ablation; association of antireflux surgery; radiofrequency ablation; and nondysplastic Barrett's esophagus., (© 2011 New York Academy of Sciences.)

Background & Aims: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE., Methods: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events., Results: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years)., Conclusions: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years., (Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Secure access and reliable closure is paramount in the setting of transesophageal mediastinal endoscopic surgery. The purpose of this study was to develop a secure transesophageal access technique and to evaluate the feasibility, safety, and efficacy of a novel covered, self-expanding, retractable stent for closure of 15-mm esophageal defects., Methods: Fifteen-millimeter esophagotomies were created in 18 domestic pigs using needle knife puncture and balloon dilatation or a blunt dissection technique. Six animals were randomly assigned to open surgical repair and six animals to endoscopic closure using a self-expanding, covered, nitinol stent (Danis SX-ELLA stent, ELLA-CS) in a nonsurvival setting. Pressurized leak tests were performed on all closures. Six animals underwent transesophageal endoscopic mediastinal interventions and survived for 17 days. Stents were extracted at day 10., Results: Nonsurvival experiments revealed two bleeding complications associated with the needle-knife access technique, while blunt-dissection mediastinal access was not associated with any complications. Leak test results were not different for stent compared to surgical closures. All survival animals were found to have complete closure and adequate healing of the esophagotomies. No leakage or infectious complication occurred., Conclusion: Blunt dissection achieves safe access into the mediastinum. Stent closure achieves similar leak test results compared to surgical closure and results in adequate sealing and wound healing of 15-mm esophageal defects.