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Background While the fiberoptic single-operator cholangiopancreatoscopy (FSOCP) system has demonstrated efficacy in the diagnosis and management of pancreaticobiliary diseases, the digital SOCP (DSOCP) appears to provide higher resolution digital imaging, however a comparison of these devices has not been established. The aim of this work was to compare the efficacy of FSOCP and DSOCP in biliary stone disease and indeterminate biliary strictures. Methods A retrospective analysis of a prospective cohort was performed in patients undergoing FSOCP or DSOCP demographics included indication, diagnostic yield, procedure time, radiation dose, and complications. Results 324 patients underwent cholangioscopy. FSOCP and DSOCP were utilized in 198 and 126 patients respectively. Male/female ratio was similar and mean age was 66 ± 13 years. Indications included stone disease, indeterminate stricture evaluation and “other” were 47%, 42% and 11% respectively. Mean procedure time for stone disease and the amount of radiation doses in DSOCP group were lower than the FSOCP group ( P = 0.032 and P = 0.02, respectively). Diagnostic yield in indeterminate strictures was higher 78% with DSOCP system compared to 37% with FSOCP system ( P = 0.004). Complication were low and similar between the groups. Conclusions DSOCP system provides enhanced diagnostic yield, shorter procedure times and less radiation exposure compared to FSOCP system.

Background and Aims Wide-area transepithelial sampling (WATS) with computer-assisted 3-dimensional analysis is a sampling technique that combines abrasive brushing of the Barrett's esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells. Methods We performed a randomized trial of referred BE patients undergoing surveillance at 16 medical centers. Subjects received either biopsy sampling followed by WATS or WATS followed by biopsy sampling. The primary outcome was rate of detection of high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) using WATS in conjunction with biopsy sampling compared with biopsy sampling alone using standard histopathologic criteria. Secondary aims included evaluating neoplasia detection rates based on the procedure order (WATS vs biopsy sampling first), of each procedure separately, and the additional time required for WATS. Results One hundred sixty patients (mean age, 63.4 years; 76% men; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 cm (interquartile range: .0-5.0) and 4.0 cm (interquartile range, 2.0-8.0), respectively. The diagnostic yield for biopsy sampling alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); nondysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy sampling yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% confidence interval, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy sampling as NDBE and 12 as LGD/indefinite for dysplasia (IND); 14 received biopsy sampling first and 9 WATS first (not significant) and most (n = 21; 91.7%) had a prior dysplasia history. WATS added an average of 4.5 minutes to the procedure. Conclusion Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC. (Clinical trial registration number: NCT03008980.)

There are limited data on the safety of endoscopic retrograde cholangiopancreatography (ERCP) during pregnancy, only data from observational series (approximately 350 cases) have been published. We aimed to evaluate the safety of ERCP in pregnant women by evaluating a large nationwide database.We performed a retrospective matched-cohort study, collecting data from the National Inpatient Sample from 2008 through 2009. We compared data from pregnant women who underwent ERCP (n = 907) with those from nonpregnant women who underwent ERCP (controls, n = 2721). Complications related to ERCP were measured against the matched controls. Obstetric and fetal complications were measured against the national average of all obstetric admissions.ERCP-associated complications of perforation, infection, and bleeding were infrequent in both cohorts (P.05). Post-ERCP pancreatitis (PEP) occurred in 12% of pregnant women and in 5% of controls (P.001). There was a significantly lower rate of PEP in teaching hospitals (9.6%) than in nonteaching hospitals (14.6%; P.001). The adjusted odds ratio for developing PEP among pregnant women vs controls was 2.8 (95% confidence interval [CI], 2.1-3.8). This risk of PEP was higher among nonteaching hospitals (adjusted odds ratio, 3.5; 95% CI, 2.3-5.2) than teaching hospitals (adjusted odds ratio, 2.5; 95% CI, 1.6-3.9).Pregnancy is an independent risk factor for PEP; PEP and PEP among pregnant women are each more prevalent in community hospitals than teaching centers. Proper precautions therefore should be considered for pregnant women undergoing ERCP, including transfer to a tertiary care center if appropriate.

Background Radiofrequency ablation (RFA) is an effective treatment for Barrett's esophagus (BE) dysplasia. For patients with dysplasia refractory to RFA, data are limited regarding efficacy of endoscopic therapy. Objective To assess the efficacy and safety of cryotherapy in patients with BE dysplasia who failed RFA. Design Single-center, retrospective, cohort study. Setting Tertiary-care center between 2006 and 2013. Patients Patients with BE and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal carcinoma (IMC) were referred for RFA every 2 to 3 months. Response was determined by complete eradication of dysplasia (CE-D). Interventions Patients without CE-D or those with recurrent dysplasia after initial eradication were offered cryotherapy. Main Outcome Measurements Eradication of dysplasia and/or cancer. Secondary outcome, eradication of intestinal metaplasia. Results A total of 121 patients underwent RFA for BE dysplasia (55% HGD, 26% LGD, 17% IMC, 2% indefinite dysplasia). After a median of 3 RFA sessions, 75% (n = 91) had CE-D. Patients without CE-D were more likely to have a longer BE length (7 cm vs 4 cm; P = .004) and a hiatal hernia (83% vs 55%; P = .005). Sixteen patients (14 with failed CE-D and 2 with recurrent dysplasia) were offered cryotherapy and had endoscopic follow-up. Seven (57%) had HGD before cryotherapy (6 with LGD, 2 with IMC, and 1 with indefinite dysplasia). After cryotherapy, 12 (75%) had CE-D, and 5 (31%) had eradication of intestinal metaplasia. Of patients with IMC, 100% had CE-D. Three patients developed strictures that responded to dilation. Limitations Single center, retrospective nature of study. Conclusion For patients with refractory dysplasia or recurrent dysplasia after RFA, salvage cryotherapy is a safe and effective endoscopic therapy.

Background and Aim American Society for Gastrointestinal Endoscopy (ASGE) guidelines have proposed criteria to stratify patients into low, intermediate and high risk of choledocholithiasis. The criteria include variables that are readily available in clinical practice. The objective of the present study was to prospectively assess the accuracy of these criteria. Methods A prospective observational cohort study was conducted at Beth Israel Deaconess Medical Center. All adult patients referred for endoscopic retrograde cholangiopancreatography (ERCP) with suspected choledocholithiasis were considered for inclusion. ASGE criteria were applied, and each patient was categorized as high, intermediate or low risk for choledocholithiasis. Presence of stone at ERCP served as criteria standard. Results During the study period, 402 patients met study inclusion criteria and 336 were reported in the final analysis. Of the 244 patients in the high risk for choledocholithiasis group, 185 were found to have stones at ERCP (75.8%, 95% CI 70.2–80.1%). Of the 92 patients in the intermediate risk for choledocholithiasis group, 45 had stones at ERCP (48.9%, 95% CI 38.8–59.1%); P-value for difference between groups = 0.001. Diagnostic accuracy for choledocholithiasis in the high-risk group was 69.05%, and for the intermediate group was 39.95%. Presence of choledocholithiasis on pre-ERCP imaging (OR: 3.6; 95% CI 2.2–6.0; P 1.8 but

Background and aim: Double-balloon enteroscopy (DBE) and single-balloon enteroscopy (SBE) are new techniques capable of providing deep enteroscopy. Results of individual studies comparing these techniques have not been able to identify a superior strategy. Our aim was to systematically pool all available studies to compare the efficacy and safety of DBE with SBE for evaluation of the small bowel. Methods: Databases were searched, including PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The main outcome measures were complete small-bowel visualization, diagnostic yield, therapeutic yield, and complication rate. Statistical analysis was performed using Review Manager (RevMan version 5.2). Meta-analysis was performed using fixed-effect or random-effect methods, depending on the absence or presence of significant heterogeneity. We used the v 2 and I 2 test to assess heterogeneity between trials. Results were expressed as risk ratios (RR) or mean differences with 95% confidence intervals (CI). Results: Four prospective, randomized, controlled trials with a total of 375 patients were identified. DBE was superior to SBE for visualization of the entire small bowel [pooled RR ¼ 0.37 (95% CI: 0.19‐0.73; P ¼ 0.004)]. DBE and SBE were similar in ability to provide diagnosis [pooled RR ¼ 0.95 (95% CI: 0.77‐1.17; P ¼ 0.62)]. There was no significant difference between DBE and SBE in therapeutic yield [pooled RR ¼ 0.78 (95% CI: 0.59‐1.04; P ¼ 0.09)] and complication rate [pooled RR ¼ 1.08 (95% CI: 0.28‐4.22); P ¼ 0.91]. Conclusions: DBE was superior to SBE with regard to complete small bowel visualization. DBE was similar to SBE with regard to diagnostic yield, ability to provide treatment and complication rate, but these results should be interpreted with caution as they is based on very few studies and the overall quality of the evidence was rated as low to moderate, due to the small sample size.

Millions of Americans have pancreatic cystic lesions, the only readily identifiable precursors of deadly pancreatic cancer. We report a light scattering spectroscopic technique that predicts the malignant potential of pancreatic cystic lesions in vivo.

Background and study aim: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. Patients and methods: This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to three private centers for obesity treatment. Results: A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m 2 ). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon removal), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. Conclusion: In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surgery.

General endotracheal (GET) anesthesia is often used during single-balloon enteroscopy (SBE). However, there is currently limited data regarding monitored anesthesia care (MAC) without endotracheal intubation for this procedure. The aim of the study was to determine the safety and efficacy of MAC sedation during SBE and to identify risk factors for adverse events. All patients who underwent SBE and SBE-assisted endoscopic retrograde cholangiopancreatography between June 2011 and July 2013 at a tertiary-care referral center were studied in a retrospective analysis of a prospectively collected database. Patients received MAC anesthesia or GET. The main outcome measurements were sedation-related adverse events, diagnostic yield, and therapeutic yield. Of the 178 cases in the study, 166 cases (93 %) were performed with MAC and 12 (7 %) with GET. Intra-procedure sedation-related adverse events occurred in 17 % of cases. The most frequent event was transient hypotension requiring pharmacologic intervention in 11.8 % of procedures. In MAC cases, the diagnostic yield was 58.4 % and the therapeutic yield was 30.1 %. Anesthesia duration was strongly associated with the occurrence of a sedation-related adverse event (P = 0.005). MAC is a safe and efficacious sedation approach for most patients undergoing SBE. Sedation-related complications in SBE are uncommon, but are more frequent in longer procedures.

Background and Aim: The optimum method for sedation for advanced endoscopic procedures is not known. Propofol deep sedation has a faster recovery time than traditional sedative agents, but may be associated with increased complication rates. The aim of the present study was to pool data from all available studies to systematically compare the efficacy and safety of propofol with traditional sedative agents for advanced endoscopic procedures. Methods: Databases including PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials updated as of January 2013 were searched. Main outcome measures were procedure duration, recovery time, incidence of complications (hypotension, hypoxia), sedation level, patient cooperation and amnesia during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and deep small bowel enteroscopy. Results: Nine prospective randomized trials with a total of 969 patients (485 propofol, 484 conscious sedation) were included in the meta-analysis. Pooled mean difference in procedure duration between propofol and traditional sedative agents was −2.3 min [95% CI: −6.36 to 1.76, P = 0.27], showing no significant difference in procedure duration between the two groups. Pooled mean difference in recovery time was −30.26 min [95% CI: −46.72 to −13.80, P < 0.01], showing significantly decreased recovery time with propofol. There was also no significant difference between the two groups with regard to hypoxia and hypotension. Conclusions: Propofol for advanced endoscopic procedures is associated with shorter recovery time, better sedation and amnesia level without an increased risk of cardiopulmonary complications. Overall patient cooperation was also improved with propofol sedation.

Background A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections. Objective To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD). Design Randomized, prospective, controlled, ex vivo study. Setting Academic medical center. Methods A total of 80 standardized artificial lesions measuring 3 × 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope. Main Outcome Measurements An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate. Results For the ESD novice, the mean submucosal dissection time (10.5 ± 3.8 vs 14.9 ± 7.3 minutes; P = .024) and total procedure time (18.1 ± 5.2 vs 23.6 ± 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 ± 6.0 minutes, conventional group 14.2 ± 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups. Limitations Ex vivo study. Conclusion In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert.

Image-guided radiation therapy allows precise tumor targeting using real-time tracking of radiopaque fiducial markers. To enable appropriate tracking, it is recommended to place fiducials with "ideal fiducial geometry" (IFG). Our objectives were to determine the proportion of patients in whom IFG can be achieved when fiducials are placed by endoscopic ultrasound (EUS) and surgery and to determine if attaining IFG is necessary for delivering radiation.This single-center retrospective cohort study included 77 patients with biopsy-proven advanced pancreatic cancer who underwent either EUS-guided or laparotomy/laparoscopy-assisted fiducial placement between September 2005 and July 2009.Gold fiducials were implanted by EUS in 39 patients (51%) and by surgery in 38 patients (49%). The proportion of patients with IFG was significantly higher for surgical placement [18/38, 47%; 95% confidence interval (CI), 32%-63%] compared with EUS-guided placement (7/39, 18%; 95% CI, 8%-32%), P = 0.0011. However, fiducial tracking was successfully used for Cyberknife therapy in 35 (90%) of 39 (95% CI, 77%-97%) patients in the EUS group compared with 31 (82%) of 38 (95% CI, 67%-92%) patients in the surgery group. There were 5 procedure-related complications in the EUS group.Achieving IFG appears unnecessary for successful tracking and delivery of radiation.

ERCP is effective for treating a bile leak (BL) after cholecystectomy (CCY), but few data exist on its effectiveness after hepatobiliary surgery (HBS).To determine the effectiveness of ERCP for treating BLs after HBS compared with BLs after cholecystectomy and to identify factors associated with treatment success.Retrospective cohort.Academic tertiary-care referral center.Patients referred from 2001 to 2009 for ERCP treatment of BL after cholecystectomy or HBS.ERCP.Resolution of BL after a single ERCP.A total of 223 patients were identified and 46 were excluded. Fifty underwent ERCP for treatment of BL after HBS and 127 after CCY. A single ERCP was successful at resolving BL in 89% of patients. Failure occurred in 7 HBS patients (14%) and 12 CCY patients (9%) (P = .379). After multiple ERCPs, success improved to 95% of the CCY group and 86% of the HBS group (P = .033). HBS patients underwent 30% more ERCPs (P = .049). ERCP was 3.3 times more likely to be successful in patients with cystic duct or duct of Luschka BLs (P = .028). Patients undergoing biliary stent placement were significantly more likely to have successful outcomes (odds ratio 71.0, P.001). Surgical history or biliary sphincterotomy did not affect outcome. Odds of treatment failure were 3.5 times higher for each additional ERCP performed (P.001).Single-center, retrospective study.ERCP is effective for treating postoperative BLs. Location of a BL and placement of a biliary stent are the best predictors of endoscopic treatment success.

Obesity is a disease that is growing in burden. It is estimated that over 1.4 billion people worldwide suffer from obesity, and 68% of Americans are considered overweight or obese. While bariatric surgery has also increased in popularity over the last two decades, the morbidity of these procedures has led investigators to develop less invasive therapies that may cause weight loss and resolution of comorbid conditions associated with obesity. There are two intragastric balloons on the market in the USA, which have been widely available in Europe and other countries, and three more remain under investigation but should be available soon. These balloons are typically placed endoscopically and are removed after a duration of months. Other novel technologies to treat obesity that are under investigation include endoscopic suturing devices to create anatomic simulations of bariatric procedures, endoluminal sleeves that create malabsorptive states, aspiration therapy to reduce caloric intake, duodenal mucosal resurfacing to induce malabsorption, and endoscopic magnetic anastomotic devices to create intestinal bypasses. These new devices may eventually become part of a growing toolbox for surgeons and endoscopists to offer therapy to morbidly obese patients in a much less invasive manner than bariatric surgery, although more data are needed.

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life. ClinicalTrials.gov identifier: NCT 02802007.

Background Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage. Objective We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage. Design Randomized, controlled, ex-vivo study. Setting Academic medical center. Methods Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum). Main Outcome Measurements Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment. Results All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested. Limitations Ex-vivo study. Conclusions In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required.

Background Because of the low sensitivity of current ERCP-guided tissue sampling methods, management of patients with indeterminate pancreaticobiliary strictures is a challenge. Probe-based confocal laser endomicroscopy (pCLE) enables real-time microscopic visualization of strictures during an ongoing ERCP. Objective To document the utility, performance, and accuracy of real-time pCLE diagnosis compared with histopathology. Design Prospective observational study within the framework of a multicenter registry. Setting Five academic centers. Patients This study involved 102 patients with indeterminate pancreaticobiliary strictures. Intervention Clinical information, ERCP findings, tissue sampling results, and pCLE videos were collected prospectively. Investigators were asked to provide a presumptive diagnosis based on pCLE during the procedure before pathology results were available. All patients received at least 30 days of follow-up until definitive diagnosis of malignancy was established or 1-year follow-up if index tissue sampling was benign. Main Outcome Measurements Diagnostic accuracy, sensitivity, specificity of ERCP-guided pCLE compared with ERCP with tissue acquisition. Results There were no pCLE-related adverse events in the study. We were able to evaluate 89 patients, of whom 40 were proven to have cancer. The sensitivity, specificity, positive-predictive value, and negative-predictive value of pCLE for detecting cancerous strictures were 98%, 67%, 71%, and 97%, respectively, compared with 45%, 100%, 100%, and 69% for index pathology. This resulted in an overall accuracy of 81% for pCLE compared with 75% for index pathology. Accuracy for combination of ERCP and pCLE was significantly higher compared with ERCP with tissue acquisition (90% vs 73%; P = .001). Limitations Investigators had access to all relevant clinical information, which may have biased the predictive characteristics of pCLE. Conclusion Probe-based CLE provides reliable microscopic examination and has excellent sensitivity and negative predictive value. The significantly higher accuracy of ERCP and pCLE compared with ERCP with tissue acquisition may support supplementing ERCP with pCLE.

This collection of summaries on endoscopic diagnosis of Barrett's esophagus (BE) includes the best endoscopic markers of the extent of BE; the interpretation of the diagnosis of ultra-short BE; the criteria for endoscopic grading; the sensitivity and specificity of endoscopic diagnosis; capsule and magnifying endoscopy; narrow band imaging; balloon cytology; the distinction between focal and diffuse dysplasia; the techniques for endoscopic detection of dysplasia and the grading systems; and the difficulty of interpretation of inflammatory or regenerative changes.

The following on endoscopic treatments of Barrett's esophagus includes commentaries on animal experiments on cryotherapy; indications for cryotherapy, choice of dosimetry, number of sessions, and role in Barrett's esophagus and adenocarcinoma; recent technical developments of RFA technology and long-term effects; the comparative effects of diverse ablation procedures and the rate of recurrence following treatment; and the indications for treatment of dysplasia and the role of radiofrequency ablation.

Training in the performance of endoscopic procedures has traditionally been given in the endoscopy suite under the supervision of a guiding physician. This approach typically results in a significant learning curve, showing enhanced cognitive skills and "hand–eye" coordination. Recent developments in medical simulation seem promising with regard to the possibility of training outside the endoscopy suite, thereby minimizing potential patient discomfort and being less stressful for both the trainee and the supervising physician. Various types of simulators are available and have been promoted as an educational tool to accelerate the training curve and to provide objective measures of procedural competency. The purpose of this paper is to review the studies performed using various simulators, comparing computer-based endoscopic simulators, animal models, and mechanical simulators with traditional endoscopy training, and to recognize the place for simulation training in a residency or fellowship program.

Fatty liver is associated with obesity, diabetes, hyperlipidemia, and the metabolic syndrome. The pathophysiology of fatty pancreas is poorly understood, but it may be closely related to fatty liver.The aim of our study was to determine the prevalence of fatty pancreas and risk factors associated with its development.Prospective, single center study.Tertiary-care academic medical center.This study involved 250 consecutive patients referred for EUS examination.All patients undergoing EUS at our institution were prospectively identified. Information regarding demographics, tobacco use, alcohol use, blood test results, and comorbidities were collected before EUS. Pancreatic echogenicity was graded in comparison to the spleen at the time of EUS by using an a priori specified grading scheme.Prevalence of fatty pancreas and factors associated with its development.During the study period, 250 consecutive patients were prospectively enrolled. The prevalence of fatty pancreas was 27.8% (95% CI, 22.1-34.1). Fatty liver was seen in 22.6% of patients. Factors associated with fatty pancreas on univariate analysis were increasing body mass index (BMI) (P=.004), fatty liver (P.0001), hyperlipidemia (P=.04), and the metabolic syndrome (odds ratio [OR] 3.13, P=.004). The presence of any metabolic syndrome components, that is, BMI≥30, hyperlipidemia, diabetes, or hypertension, increased the prevalence of fatty pancreas by 37% (OR 1.37, P=.01). Factors independently associated with fatty pancreas on multivariate analysis were increasing BMI (OR 1.05, P=.03) and fatty liver (OR 3.61, P.001). We found no association between fatty pancreas and chronic pancreatitis or adenocarcinoma of the pancreas.Single institution study. All patients were referred for EUS, which limits generalizability. Lack of histological confirmation of pancreatic fat.We found a strong association between fatty pancreas and the metabolic syndrome.

Laparoscopic distal pancreatectomy is associated with high morbidity and mortality. NOTES tumor enucleation may provide an alternative to laparoscopic distal pancreatectomy. The goal of this study was to determine the feasibility of NOTES tumor creation and enucleation as a multidisciplinary approach.A linear-array endoscopic ultrasound (EUS) endoscope was used to inject a thermosensitive ABA triblock polymer mixed with methylene blue through the stomach wall and into the distal pancreas using a 22-gauge EUS needle. Due to its thermosensitive character, the polymer solidifies in response to body temperature, creating an artificial tumor. Seventeen swine underwent NOTES transgastric pancreatic tumor enucleation. Nine nonsurvival animals were sacrificed immediately after the NOTES procedure, with subsequent necropsy. Eight survival animals were observed for up to 16 days after the procedure, subsequently sacrificed, followed by necropsy.The procedure was performed successfully in all 17 pigs studied, 9/9 nonsurvival (100%) and 8/8 survival (100%) animals, using a pure NOTES approach without any laparoscopic ports. Complications included two esophageal dissections (1 in nonsurvival group, 1 in survival group) caused by the introduction of the endoscopic overtube (2/17, 12%), unrelated to the actual surgical procedure. In the survival animals, there were two small splenic lacerations caused during retraction with the endoscopic forceps, for which hemostasis was achieved prior to closure of the gastrotomy (2/7, 29%). At necropsy of the animals, there was sufficient closure of 15/17 gastrotomy sites (88%).The creation of artificial pancreatic tumors via EUS guidance is feasible. Pancreatic tumor enucleation using a transgastric NOTES approach is technically feasible and could be an alternative to laparoscopic distal pancreatectomy with further development. Further adoption and adaptation of this technique will require the development of more sophisticated specialized tools to improve the safety profile of the procedure.

Background Optimizing the visualization of the cutting line of the submucosal layer is essential to performing an effective and safe endoscopic submucosal dissection (ESD). Objective To evaluate the prototype R-scope compared with a conventional, double-channel endoscope in time required for ESD of mucosal lesions in distinct anatomical locations of the stomach. Design A prospective, comparative, ex vivo study. Intervention ESD. Main Outcome Measurements Procedure time (primary end point measure), specimen size, submucosal injection frequency, en bloc resection rate, and perforation rate (secondary end point measures). Results In the subgroup of resections in the greater and lesser curvature, the mean (± SD) procedure time was significantly less in the R-scope group compared with the conventional endoscope group (8.4 ± 2.1 minutes vs 11.3 ± 2.1 minutes, respectively; P = .006), and the mean (± SD) submucosal injection frequency was significantly less in the R-scope group compared with the conventional endoscope group (1.9 ± 0.6 vs 2.5 ± 0.5, respectively; P = .025). There were no significant differences in procedure time, specimen size, submucosal injection requirements, en bloc resection rate, and perforation rate between the two endoscopic groups of all combined anatomic lesions. Limitations Small, ex vivo study. Conclusion ESD by using the R-scope may provide an improved platform for quicker ESD, especially in greater and lesser curvature anatomical lesions of the stomach.

Esophageal adenocarcinoma is the most rapidly growing cancer in America. Although the prognosis after diagnosis is unfavorable, the chance of a successful outcome increases tremendously if detected early while the lesion is still dysplastic. Unfortunately, the present standard-of-care, endoscopic surveillance, has major limitations, since dysplasia is invisible, often focal, and systematic biopsies typically sample less than one percent of the esophageal lining and therefore easily miss malignancies. To solve this problem we developed a multispectral light scattering endoscopic imaging system. It surveys the entire esophageal lining and accurately detects subcellular dysplastic changes. The system combines light scattering spectroscopy, which detects and identifies invisible dysplastic sites by analyzing light scattered from epithelial cells, with rapid scanning of the entire esophageal lining using a collimated broadband light beam delivered by an endoscopically compatible fiber optic probe. Here we report the results of the first comprehensive multispectral imaging study, conducted as part of routine endoscopic procedures performed on patients with suspected dysplasia. In a double-blind study that characterized the system’s ability to serve as a screening tool, 55 out of 57 patients were diagnosed correctly. In addition, a smaller double-blind comparison of the multispectral data in 24 patients with subsequent pathology at locations where 411 biopsies were collected yielded an accuracy of 90% in detecting individual locations of dysplasia, demonstrating the capability of this method to serve as a guide for biopsy. An imaging technique that can help detect early stage esophageal cancer has been shown to be highly effective. Developed by Lev Perelman, Le Qiu and colleagues from Harvard University the approach combines a scanning endoscopic fiber probe with multispectral light scattering spectroscopic imaging to detect subcellular dysplastic changes in the esophageal lining. Dysplasia, an abnormal change in biological tissue, is an important signature of precancer but can be hard to detect. In a series of double-blind studies to assess the approach's effectiveness as a screening tool the Harvard team report that their technique diagnosed 55 out of 57 patients correctly and also had a 90% accuracy rate in detecting dysplasia in biopsies that had been taken. The portable system makes use of broadband LED as a light source and fits into a case.

Esophageal cancer is increasing in frequency in the United States faster than any other cancer. Barrett's esophagus, an otherwise benign complication of esophageal reflux, affects approximately three million Americans and precedes almost all cases of esophageal cancer. If detected as high-grade dysplasia (HGD), most esophageal cancers can be prevented. Standard-of-care screening for dysplasia uses visual endoscopy and a prescribed pattern of biopsy. This procedure, in which a tiny fraction of the affected tissue is selected for pathological examination, has a low probability of detection because dysplasia is highly focal and visually indistinguishable. We developed a system called endoscopic polarized scanning spectroscopy (EPSS), which performs rapid optical scanning and multispectral imaging of the entire esophageal surface and provides diagnoses in near real time. By detecting and mapping suspicious sites, guided biopsy of invisible, precancerous dysplasia becomes practicable. Here we report the development of EPSS and its application in several clinical cases, one of which merits special consideration.

Despite advances in imaging, differentiating benign from malignant causes of pancreatic duct dilation is difficult.The aim of our study was to assess the accuracy of the periductal hypoechoic sign (PHS), defined as patchy hypoechoic areas adjacent to a dilated pancreatic duct, for the diagnosis of pancreatic malignancy.Single-center, retrospective analysis.Tertiary care university hospital.All patients who underwent EUS from 2006 to 2008 for evaluation of pancreatic pathology were identified. Those with pancreatic duct dilation of 4 mm or more in the head of the pancreas or 3 mm or more in the body or tail were included. Digitally recorded EUS images were analyzed for PHS by 1 endoscopist blinded to final results. The final diagnosis was based on pathology results or clinical follow-up.During the study period, 84 of 427 patients who underwent EUS for pancreas pathology had dilated pancreatic ducts. Of these, 42 patients had benign disease and 42 had pancreatic malignancy. The PHS was noted in 31 (73.8%) of 42 patients with malignancy compared with 6 (14.3%) of 42 patients with benign disease (P.001). The PHS had a sensitivity of 73.8%, a specificity of 85.7%, and an accuracy of 79.8% for the diagnosis of pancreatic malignancy. After adjusting for age, patients with the PHS were 17 times more likely to have a malignancy (odds ratio 16.66; 95% CI, 5.01-55.44). Pancreatic duct diameter or dilation of both bile and pancreatic ducts were not predictive of malignancy.A retrospective design.The PHS was an accurate and independent predictor of pancreatic malignancy in patients with a dilated pancreatic duct.

Background & Aims International consensus guidelines, aimed at predicting malignancy, are available for surgical resection of mucinous cysts but not for other cystic lesions of the pancreas. We sought to determine whether the consensus guidelines can be applied to all cystic lesions of the pancreas. Methods We identified all patients who underwent surgical resection of pancreatic cysts from 2001–2007. Pathology analyses of surgical specimens served as the reference standard. Surgical resection criteria proposed by the Sendai Guidelines and 5 modifications of these criteria were tested to determine their accuracy for diagnosis of malignant cysts. Results Patients with cystic lesions of the pancreas (n = 154; mean age, 59.8 years; 64% women) underwent resection and met prespecified study criteria. Twenty-one patients had a malignancy. The classification cyst size ≥3 cm had an accuracy of 56%, negative predictive value of 84%, and identified only 57% of the malignant cysts. The classification cyst size ≥3 cm or cyst with main pancreatic duct ≥10 mm had an accuracy of 55%, negative predictive value of 86%, and identified 66% of malignant cysts. The modified criterion of cyst size ≥3 cm or cyst with main pancreatic duct >3 mm had an accuracy of 48%, negative predictive value of 94%, and identified 91% (19/21) of the malignancies. Cyst size (odds ratio, 1.05) and pancreatic duct dilation >3 mm (odds ratio, 10.5) were strong and independent predictors of malignancy. Conclusions When applied to all cystic lesions of the pancreas, the international consensus criteria cause some malignant cysts to be missed. Modified criteria could identify most malignant cysts, although overall accuracy remains low.

Background Covered self-expandable metallic stents (SEMSs) are designed to prevent tumor ingrowth and can be removed if necessary. Only limited comparative data are available on the performance of covered SEMSs after primary placement versus reintervention. Objective To assess the effectiveness and safety of covered SEMS placement either as primary treatment or reintervention in patients requiring palliation of malignant biliary obstruction. Design Retrospective clinical cohort study. Setting Tertiary referral center. Patients This study involved 104 patients with unresectable malignant biliary strictures. Intervention Covered biliary SEMS placement. Main Outcome Measurements Stent patency, technical success, and patient survival. Results Covered SEMSs were placed as primary treatment in 48 patients (46%), and reintervention was performed in 56 patients (54%). At 3, 6, and 12 months thereafter, the Kaplan-Meier estimated fractions of all patients with patent stents were 94%, 84%, and 58%, respectively. Covered SEMSs remained patent until the patient's death in 75 of 89 nonsurvivors (84%). Although patency rates 3, 6, and 12 months after primary placement (100%, 93%, and 82%, respectively) were higher than those after reintervention (90%, 78%, and 48%, respectively), the differences were not statistically significant ( P = .057). Overall, the most frequent adverse events were cholangitis (7%) and stent migration (4%). Limitations The distribution of stricture locations differed among the groups, and survival data suggested the presence of more extensive disease in the primary treatment group at baseline. Conclusion The clinical utility and safety of primary covered SEMS placement were confirmed. This study provides the most extensive evidence to date that reintervention with a covered SEMS can provide a useful palliative option.

Background Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. Platelet-activating factor (PAF) has been implicated in the pathophysiologic events associated with acute pancreatitis. Animal and human studies suggested that recombinant PAF acetylhydrolase (rPAF-AH) might ameliorate the severity of acute pancreatitis. Objective Our purpose was to determine whether prophylactic rPAF-AH administration reduces the frequency or severity of post-ERCP pancreatitis in high-risk patients. Design Randomized, multicenter, double-blind, placebo-controlled study. Interventions Patients received rPAF-AH at a dose of either 1 or 5 mg/kg or placebo. Patients were administered a single intravenous infusion over 10 minutes of study drug or placebo Main Outcome Measurements Standardized criteria were used to diagnose and grade the severity of post-ERCP pancreatitis. Adverse events were prospectively recorded. Results A total of 600 patients were enrolled. There were no statistically significant differences among the treatment groups with respect to patient demographics, ERCP indications, and patient and procedure risk factors for post-ERCP pancreatitis with the following exceptions: the rPAF-AH 5 mg/kg group had significantly fewer patients younger than 40 years old and scheduled to undergo a therapeutic ERCP involving the pancreatic sphincter or duct. Post-ERCP pancreatitis occurred in 17.5%, 15.9%, and 19.6% of patients receiving rPAF-AH (1 mg/kg), rPAF-AH (5 mg/kg), and placebo, respectively ( P = .59 for rPAF-AH 1 mg/kg vs placebo and P = .337 for rPAF-AH 5 mg/kg vs placebo). There was no statistically significant difference between the groups with regard to the severity of pancreatitis, frequency of amylase/lipase elevation more than 3 times normal, or abdominal pain. Conclusions There was no apparent benefit of rPAF-AH treatment compared with placebo in reducing the incidence of post-ERCP pancreatitis in subjects at increased risk.

Background & Aims Practice guidelines recommend that endoscopists spend at least 7 minutes examining the colonic mucosa during colonoscopy withdrawal to optimize polyp yield. The aim of this study was to determine if the implementation of an institution-wide policy of colonoscopy withdrawal time ≥7 minutes was associated with an increase in colon polyp detection. Methods All 42 endoscopists at our institute were asked to attain a colonoscopy withdrawal time of at least 7 minutes. Compliance with 7-minute withdrawal time was recorded for all nontherapeutic colonoscopies. Polyp detection ratio (number of polyps detected divided by number of colonoscopies performed) was computed. Regression models were used to assess the association between compliance with 7-minute withdrawal time and polyp detection. Results During the study period, 23,910 colonoscopies were performed. The average age of patients was 56.8 years, and 54% were female. Colon cancer screening or surveillance was the indication for 42.5% of colonoscopies. At the beginning of the study, the polyp detection ratio was 0.48. Compliance with 7-minute withdrawal time for nontherapeutic procedures increased from 65% at the beginning of the initiative to almost 100%. However, no increase in polyp detection ratio was noted over the same period for all polyps (slope, 0.0006; P = .45) or for polyps 1–5 mm (slope, 0.001; P = .26), 6–9 mm (slope, 0.002; P = .43), or ≥10 mm (slope, 0.006; P = .13). No association was detected when only colonoscopies performed for screening or surveillance were analyzed. Conclusions An institution-wide policy of colonoscopy withdrawal time ≥7 minutes had no effect on colon polyp detection.

The incidence of adenocarcinoma of the esophagus is increasing more rapidly than any other type of carcinoma in the United States. Almost 100% of cases occur in patients with Barrett’s esophagus, a benign condition in which metaplastic columnar epithelium replaces the normal squamous epithelium of the esophagus. Although the prognosis of patients diagnosed with adenocarcinoma is poor, the chances of successful treatment increase significantly if the disease is detected at the dysplastic stage. Recently, we developed the clinical endoscopic polarized light scattering spectroscopy imaging instrument which performs rapid optical scanning and multispectral imaging of the entire esophageal surface and provides diagnoses in near real time. By detecting and mapping suspicious sites, guided biopsy of invisible, precancerous dysplasia becomes practicable.

Objective To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon–based ablation device (HALO 360 System). Design This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm 2 ) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm 2 . The effectiveness phase used 10 J/cm 2 (delivered twice [×2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months. Setting Eight U.S. centers, between September 2003 and September 2005. Patients Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment. Results In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm 2 (×2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70% of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated). Conclusions Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70% of patients at 1-year follow-up.

There is limited data regarding the prevalence and clinical impact of sedation-related adverse events (SRAEs) during radiofrequency ablation (RFA) for dysplastic Barrett’s esophagus (BE). Our primary aim was to measure SRAE during RFA. Secondary aims were to identify risk factors for adverse events, and to determine whether SRAEs impacted the number of RFA treatments to achieve complete eradication of dysplasia (CE-D). We conducted a retrospective analysis of 120 consecutive patients undergoing initial RFA for dysplastic BE between 2008 and 2014. The main outcome measures were SRAEs and the number of RFA sessions required to achieve CE-D. Of 120 initial RFA procedures, 83 % were performed with MAC and 17 % with GET. SRAEs occurred in 32 %, including 25 % of MAC patients (25/100) and 65 % (12/20) GET patients. The most frequent SRAE was hypotension (23 %, n = 27/120), followed by hypoxia (n = 9/120), arrhythmia (n = 4/120), and one unplanned intubation. There were no premature procedure terminations. After adjusting for length of BE mucosa and ASA score, the occurrence of a SRAE was associated with requiring more (>4) RFA sessions to achieve CE-D, OR 3.45 (95 % CI 1.49–7.99). Mean RFA sessions required to achieve CE-D was 5 ± 1 in patients with SRAE, compared to 3 ± 0.7 in patients without SRAE during the first treatment session (p

Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon.Eight patients (mean BMI = 31.0 kg/m(2)) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed.All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities.This pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

Advances in endoluminal instrumentation and technology are enabling endoscopists to perform increasingly sophisticated procedures. Indications for these procedures are likely to expand as outcomes studies show they are efficacious and cost-effective. This article highlights several recent advances in endoluminal suturing, dissecting, and ligating and discusses the impact of these advances on the practice of gastrointestinal surgery. Endoluminal suturing offers select patients with gastroesophageal reflux disease a safe and effective alternative to laparoscopic surgery. Devices designed for endoluminal hemostasis and endoscopic mucosal resection can be used effectively for a broader range of applications and are already being used to perform transluminal surgery in animal models; human trials are forthcoming. Gastrointestinal surgeons should support efforts to critically evaluate endoluminal techniques because they have an opportunity to improve care. Surgical residents planning careers in gastrointestinal surgery need to understand endoscopic techniques and consider their training opportunities.

The endoscopic full-thickness plication device is designed to inhibit reflux with a single plication near the gastroesophageal junction. Full-thickness plication of the proximal stomach may improve the competency of the gastroesophageal barrier by restoring the valvular mechanism of the gastroesophageal junction. Other potential mechanisms include alteration of the angle of His, and reduction of the compliance of the gastric cardia and fundus. The procedure is easily and safely performed and, in the human pilot study, has been shown to reduce symptoms and medication use associated with gastroesophageal reflux disease.