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Background: Refractory benign esophageal strictures (RBES) are defined as those that persist structurally and symptomatically after repeated dilation sessions. Small series have reported favorable outcomes after placement and subsequent removal of Polyflex self-expanding plastic stents (SEPS).Aims: To characterize the outcomes after Polyflex stent placement in patients with RBES.Methods: Outcomes of consecutive patients who underwent Polyflex stent placement for RBES between April 15, 2005 and November 20, 2006 were analyzed retrospectively. The etiology of the stricture, number of dilations prior to initial SEPS placement, size of stent placed, stricture resolution after SEPS removal, cases of stent migration, duration of SEPS placement, time to repeat dilation and/or SEPS replacement after stent removal, and complications were assessed.Results: Twenty-three Polyflex stents were placed in 13 patients suitable for analysis. The majority of stenoses (11/13) were attributable to anastomotic strictures after curative esophagogastrectomy for esophageal neoplasms. All 11 patients in this group had satisfactory relief of dysphagia to solids determined clinically with indwelling SEPS placement. SEPS migration occurred in seven instances (30% of SEPS placed). Dysphagia remediation after subsequent SEPS removal was observed in only three patients (23%). Placement of a partially covered metal stent within a Polyflex stent was necessary in one case due to epithelial hyperplasia. The mean time for repeat dilation and/or SEPS reinsertion due to recurrent dysphagia after stent removal was 37 days (range 6-120 days).Conclusions: Polyflex stents provided satisfactory palliation of dysphagia for RBES while in place. However, unplanned SEPS migration and dysphagia recurrence after stent removal were common. [ABSTRACT FROM AUTHOR]

BACKGROUND AND AIMS: It is unknown how physician specialties other than gastroenterologists that manage gastrointestinal (GI) malignancies utilize endoscopic ultrasound (EUS) in their practices. The aim of this study was to (i) assess the proportion of gastroenterologists, oncologists, and surgeons that utilize EUS for staging of GI malignancies; (ii) assess the general availability of EUS; and (iii) determine which factors are associated with the use and availability of EUS. METHODS: A self-administered questionnaire was mailed out to 1,200 randomly selected gastroenterologists, oncologists, and surgeons throughout the United States. RESULTS: The data was analyzed from 521 (43%) responses. There were 60% respondents who had EUS available within their practices. There was greater availability of EUS within the practices of surgeons (81%; p < 0.001), within academic practices (87%; p= < 0.001), and in practices that serve a population >500,000 ( p < 0.001). The majority of respondents (71%) utilized EUS in their practices. There was a similar utilization of EUS across specialties ( p= NS). There was greater utilization of EUS in academic centers (82%; p < 0.001), in practices that served a community of >500,000 ( p= 0.003), and among respondents who had been in practice for less than 5 yr ( p= 0.005). Employing logistic regression models for utilization of EUS, lesser number of years in practice, and availability of EUS were found to be the only significant predictors of utilization. CONCLUSIONS: The majority of practitioners utilized EUS in management of GI malignancies. There was similar utilization of EUS across specialties. EUS is available to the majority of practitioners who manage GI malignancies. [ABSTRACT FROM AUTHOR]

Heterotopic pancreatic tissue, also known as a pancreatic rest, is an uncommon congenital anomaly defined as extrapancreatic tissue located far from the pancreas and without connection via vascular or anatomical means to it. Such tissue may occur throughout the GI tract but has a propensity to affect the stomach and the proximal small intestine. The majority of patients with pancreatic heterotopia are asymptomatic, but when symptoms occur, they can present in a variety of ways. We report a case of a patient whose pancreatic rest presented primarily as dysphagia for solid food and in whom endoscopic ultrasound was used to further define the lesion. There have been only two cases reported of a pancreatic rest causing symptoms of dysphagia. A review of the literature on pancreatic heterotopia as well as the use of endoscopic ultrasound as an aid in evaluation is included. [Copyright &y& Elsevier]

An editorial is presented which discusses on the use of biodegradable endoprosthetic stents, as a new technological medical surgery device in the treatment of the benign esophageal strictures.

A letter to the editor is presented regarding an unusual cause of colonic obstruction.

Given their malignant potential, resection of esophageal granular cell tumors (GCTs) is often undertaken, yet the optimal technique is unknown. We present a large series of dedicated endoscopic resection using band ligation (EMR-B) of esophageal GCTs. Patients diagnosed with esophageal GCTs between 2002 and 2019 were identified using a prospectively collected pathology database. Endoscopic reports were reviewed, and patients who underwent dedicated EMR-B of esophageal GCTs were included. Medical records were queried for demographics, findings, adverse events, and follow-up. We identified 21 patients who underwent dedicated EMR-B for previously identified esophageal GCT. Median age was 39 years; 16 (76%) were female. Eight (38%) had preceding signs or symptoms, potentially attributable to the GCT. Upon endoscopic evaluation, 12 (57%) were found in the distal esophagus. Endoscopic ultrasound was used in 15 cases (71%). Median lesion size was 7 mm, interquartile range 4 mm—8 mm. The largest lesion was 12 mm. A total of 20 (95%) had en bloc resection confirmed with pathologic examination. The only patient with tumor extending to the resection margin underwent surveillance endoscopy that showed no residual tumor. No patients experienced bleeding, perforation, or stricturing in our series. No patients have had known recurrence of their esophageal GCT. EMR-B of esophageal GCT achieves complete histopathologic resection with minimal adverse events. EMR-B is safe and effective and seems prudent compared with observation for what could be an aggressive and malignant tumor. EMR-B should be considered first-line therapy when resecting esophageal GCT up to 12 mm in diameter. [ABSTRACT FROM AUTHOR]

Simple Summary: This study explores the psychosocial impact of pancreatic cancer (PC) surveillance in individuals at high-risk (HRIs) of developing PC. The primary objective was to understand the attitudes and beliefs of HRIs undergoing PC surveillance and assess the immediate and sustained psychosocial effects. By investigating factors such as perceived benefits, self-efficacy, and emotions before and after surveillance, the study aims to shed light on the overall experience of PC surveillance. The findings suggest that PC surveillance can yield lasting psychosocial benefits for HRIs. This insight not only enhances our understanding of the social and psychological aspects of surveillance, but also has implications for how the medical community approaches and supports individuals in high-risk PC surveillance programs. Objectives: Pancreatic cancer (PC) surveillance of high-risk individuals (HRIs) downstages PC and improves survival. However, it remains less clear whether PC surveillance has a positive psychosocial impact on HRIs. Herein, we aimed to define the attitudes and beliefs of HRIs undergoing PC surveillance, and the immediate and sustained psychosocial impact of PC surveillance in HRIs. Methods: 100 HRIs undergoing PC surveillance by endoscopic ultrasound (EUS) completed three surveys addressing different components of the psychosocial impact of PC surveillance. Logistic regression analyses were performed to identify predictive factors relating to these components. Results: Most HRIs reported increased perceived benefits of PC surveillance, self-efficacy, and perceived severity of PC. HRIs reported few negative emotions prior to surveillance and frequent positive emotions after surveillance. Compared to prior to surveillance, there was a 53.5% decrease in the level of distress reported by HRIs after surveillance, which was sustained for 4–6 weeks post-surveillance. Family history of PC and lower self-reported mental health were identified as predictors for increased perceived susceptibility to PC (p < 0.01) and greater change in distress pre- to post-surveillance (p < 0.01), respectively. Conclusions: Our findings suggest that PC surveillance can lead to sustained psychosocial benefits in HRIs. [ABSTRACT FROM AUTHOR]

Background and Aim: Tumor genotyping may allow for improved prognostication and targeted therapy for pancreatic ductal adenocarcinoma (PDAC). We aimed to compare endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) to fine needle biopsy (FNB) for obtaining sufficient tissue for genomic analysis and theranostic potential. Methods: A retrospective cohort study of patients that underwent EUS‐FNA or EUS‐FNB with either positive or suspicious cytology for PDAC between March 2016 and December 2017. Demographic, procedural, and cytology data were recorded. Genetic alterations were recorded, and Kaplan–Meier survival curves were calculated. Results: The study included 167 patients: 145 patients had FNA and 22 patients underwent FNB. Overall, 117 samples (70.1%) were sufficient for targeted next‐generation sequencing. FNB resulted in a higher proportion of patients with sufficient samples compared with FNA (90.9% vs 66.9%; P = 0.02). In multivariable modeling, only FNB (odds ratio 4.95, 95% confidence interval 1.11–22.05, P = 0.04) was associated with sufficient sampling for genomic testing. FNB was more likely to obtain sufficient tissue from tumors ≤ 3 cm (100% vs 68.4%, P = 0.017) and tumors located in the head/neck of the pancreas (100% vs 63.1%, P = 0.03) compared with FNA. The most commonly identified alterations were in KRAS (88%), TP53 (68%), and SMAD4 (16%). Conclusions: Endoscopic ultrasonography can reliably obtain sufficient tissue from PDAC for targeted genomic sequencing for prognostication and theranostics. FNB should be considered when tumor genotyping is requested, especially for tumors ≤ 3 cm or tumors located in the head/neck of the pancreas. [ABSTRACT FROM AUTHOR]

PURPOSE: An effective blood-based test for pancreatic cancer (PC) screening has remained elusive. The IMMray PanCan-d is the first commercially available blood-based test specifically designed for early detection of PC; however, outcomes from its use in clinical practice have not been reported. METHODS: We performed a blinded spike-in study of 100 individuals who had an IMMray PanCan-d test, including 94 high-risk individuals (HRIs) undergoing PC surveillance and six individuals with known PC. Specimens were processed blindly following the commercial laboratory's standardized operating procedure. Positive predictive value (PPV) and negative predictive value (NPV) were calculated. RESULTS: Cohort characteristics included a median age of 63 (IQR, 55-70) years, 57% female, 96% non-Hispanic White, 57% with a pathogenic variant in a PC risk gene (BRCA2 most commonly—18%), and 83% with a family history of PC. Among IMMray PanCan-d results from 94 HRIs undergoing PC surveillance, there was one positive (1%), seven borderlines (7%), 73 negatives (78%), and 13 tests not performed because of low CA19-9 expression (14%). No PC was diagnosed among these HRIs; however, there were two sub-cm pancreatic neuroendocrine tumors, seven clinically diagnosed side branch intraductal papillary mucinous neoplasms ≥1 cm, and a sub-cm solid mass with indeterminate cytology requiring close follow-up; all these individuals had negative IMMray PanCan-d tests. Of the six spiked-in PCs, four (67%) yielded a positive and two (33%) yielded a negative. With an estimated disease prevalence of 2%, the PPV and NPV are 52% and 99%, respectively, if borderline results are considered negative and 12% and 99%, respectively, if borderline tests are considered positive. CONCLUSION: In clinical practice, IMMray PanCan-d has a robust NPV; however, PPV is dramatically influenced by whether borderline results are characterized as a positive or negative result. The IMMray PanCan-d is the first commercially available blood-based test specifically designed for early detection of pancreatic cancer, and we assessed the outcomes of this test in high-risk individuals undergoing pancreatic cancer surveillance. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor along with its response commenting on computed tomography versus endoscopic ultrasonography for staging of pancreatic cancer. Discussion on the protocol of performing endoscopic ultrasonography; Views on methods to deem tumors; Highlights on the medical tests performed.

Background/aims: Endoscopic closure is technically feasible in the majority of gastrointestinal defects. The aim of this study is to evaluate the technical and clinical outcomes, and identify variables predicting successful outcomes in patients with attempted closure. Methods: This is a retrospective study of patients undergoing endoscopic closure of gastrointestinal defects between December 2007 and May 2013 at a single tertiary care center. Technical success (TS) was defined as successful closure of the defect at the time of endoscopy. Clinical improvement (CI) was defined as improvement in symptoms. Clinical resolution (CR) was defined as documented radiographic closure of defect or clinical resolution of symptoms. Acute defects were diagnosed within 6 weeks, while chronic defects were those that persisted for >6 weeks, prior to index therapeutic endoscopy. Results: Fifty patients underwent 77 endoscopies for leaks ( n = 23), fistulas ( n = 22), and perforations ( n = 5). TS occurred in 46/50 (92 %). Overall, 34/50 (68 %) patients had CR. CR was significantly higher for acute defects as compared to chronic defects (89.7 vs. 38.1 %, OR 14.1, CI 3.19-62.1, p < 0.001). Of 24 patients who required repeat attempts at endoscopic closure, 14 (58 %) achieved CR. Acute defects ( p = 0.04) and those with initial CI ( p = 0.001) were statistically more likely to achieve CR after a repeat attempt. Conclusion: TS and CR are achieved in majority of patients. Acute defects are more likely to achieve CR. In cases where a defect persists, a repeat attempt at endoscopic closure should be attempted. [ABSTRACT FROM AUTHOR]

Background In 2006, the Sendai Consensus Guidelines identified size >3.0 cm as the only independent predictor of malignancy in incidentally discovered pancreatic cysts. The 2012 updated guidelines increased emphasis on radiographic features over size. Earlier studies included patients with preoperatively diagnosed carcinoma or with a corresponding mass. In this report, we characterize the use of size and serum tumor markers in the initial evaluation of pancreatic cystic neoplasms without preoperatively diagnosed adenocarcinoma and correlate them with clinical and pathologic outcomes. Study Design A retrospective cohort study was undertaken of 112 patients with a resected pancreatic cystic neoplasm. Patient demographics, cyst characteristics, preoperative serum tumor markers, morbidity, and mortality were captured. Statistical analysis included nonparametric tests of comparison, multivariate logistic regression, and receiver operating characteristic curve analyses. Results One hundred and twelve pancreatic cystic neoplasms were resected; there was one perioperative death. Mucinous cysts were common (78%), followed by serous cysts (13%). In total, 17% of cysts harbored malignancy. On multivariate analysis, the risk of malignancy in cysts ≥3 cm was more than 4 times that of smaller cysts (relative risk (RR) = 4.32; 95% CI, 1.55–12.07). There was no significant difference in serum CEA, cancer antigen 19-9, or cyst-fluid CEA levels between the benign and malignant groups. At a median follow-up of 30 months, the incidence of diabetes was 15%. Conclusions Surgical resection of pancreatic cysts can be performed with low perioperative mortality and acceptable long-term morbidity. Use of cyst size as a rationale for resection of cystic lesion, as per the Sendai criteria, is justified. [ABSTRACT FROM AUTHOR]

The article highlights the impact of COVID-19 on Endoscopic training. It focuses on to preserve personal protective equipment and minimize exposure, as many fellowship programs prohibiting fellows from participating in endoscopy; also highlights Gastroenterology fellowship as unique to teach both procedural and cognitive skills.

Argon plasma coagulation (APC) is a standard modality for the treatment of gastrointestinal bleeding. However, there are no metrics to assess technical proficiency. We aimed to determine if a Quick APC Training Test (QAPCTT) can improve performance and assess proficiency with this modality. Endoscopy trainees at various levels of training were asked to perform the QAPCTT with an in vivo model before and after an APC curriculum with didactic lectures and additional hands-on experience. As trainees performed the test, endoscopic supervisors recorded the time required to complete each task as well as the number of inadvertent mucosal touchdowns. Each partipant was assigned a technical proficiency score by supervising endoscopists. Fourteen adult gastroenterology fellows participated in the course. 100% of fellows were comfortable with generator settings and APC equipment after the course compared to only 21% (p < 0.001) on the pre-test questionnaire. Those deemed technically proficient on the post-course QAPCTT required significantly less time for the task of making a square (100 s vs. 215 s; p = 0.006) and had significantly fewer inadvertent mucosal touchdowns (5 vs. 19; p = 0.0017). Dedicated APC training is required to achieve competence with this modality. A structured curriculum improves knowledge about the technique and hands-on training is important for achieving technical proficiency. The QAPCTT appears improve APC technique and may readily identify trainees in need of additional APC experience to gain proficiency. [ABSTRACT FROM AUTHOR]

A reprint of an article on concerns of carbapenem-resistant Enterobacteriaceae (CRE) infection is presented which was published online in the website of the journal on September 22, 2015. Topics discussed include links of the infection with contaminated duodenoscopes, safety measures for healthcare providers on duodenoscope cleaning, and inefficacy of sterilization on the infection.

Purpose: To investigate advanced neoplasia (AN) after endoscopic mucosal resection (EMR) of colonic laterally spreading lesions (LSLs).Methods: A retrospective study of patients who underwent injection-assisted EMR of colonic LSLs ≥ 10 mm was performed. Primary outcome was overall rate of AN at initial surveillance colonoscopy. Secondary outcomes were the rates of residual AN (rAN) at the EMR site and metachronous AN (mAN), and analysis of risk factors for AN, including effect of surveillance guidance.Results: Three hundred seventy-four patients underwent successful EMR for 388 LSLs. AN occurred in 66/374 (17.6%) patients on initial surveillance colonoscopy at median follow-up of 364.5 days. Two patients had both rAN and mAN, for a total of 68 instances of AN, including 30/374 (8.0%) cases of rAN and 38/374 (10.2%) cases of mAN. On multivariate analysis, use of piecemeal resection was associated with increased likelihood of residual AN (P = 0.003, OR 9.2, 95% CI 2.1-33.3). Twenty-nine out of thirty cases (96.7%) of rAN were successfully endoscopically managed at surveillance colonoscopy.Conclusions: AN occurred in 17.6% of all patients at initial surveillance colonoscopy at a median of 1 year after EMR. Roughly half of the instances of AN were metachronous lesions. Our data support a 1-year surveillance interval after EMR of LSLs ≥ 10 mm with careful inspection of the entire colon, not just the prior resection site. [ABSTRACT FROM AUTHOR]

Introduction: The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy.Methods: Ninety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes.Results: There were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p = 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p < 0.05).Conclusion: The safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification. [ABSTRACT FROM AUTHOR]

Background: Sessile serrated polyps (SSPs) are associated with higher rates of incomplete resection compared to conventional adenomas after traditional snare polypectomy. Outcomes after endoscopic mucosal resection (EMR) are less established. The aim of this study was to evaluate the rate of residual neoplasia at surveillance colonoscopy for SSPs compared to conventional adenomas ≥ 10 mm after en bloc EMR.Methods: Retrospective cohort study of consecutive patients referred for EMR of a colonic lesion ≥ 10 mm from 2005 to 2013. Data on procedures, histopathology, and surveillance colonoscopies were recorded. The primary outcome was rate of macroscopically evident residual neoplasia at surveillance colonoscopy for SSPs compared to adenomas. Secondary outcomes included rate of neoplasia at the resection margin.Results: 283 consecutive patients with 293 polyps underwent en bloc EMR including 101 SSPs and 192 adenomas. Pathology commented on the lateral resection margins of the specimen in 235 cases (80%). Of these, neoplasia was noted at the resection margin in 29/64 SSPs (45.3%) compared to 65/171 adenomas (38.0%; P = .37). Surveillance data were available for 153 index lesions with a median interval of 13 months (interquartile range, 10.75-23.25 months). Ten resection sites (6.5%) were found to have residual neoplasia, including 2/52 SSPs (3.8%) and 8/101 adenomas (7.9%; P = .50). Of the cases with surveillance data 128/153 (84%) commented on the lateral margin of the resection specimen. Residual neoplasia was noted in 3/68 lesions (4.4%) with negative margins compared to 5/60 lesions (8.3%) with positive margins (P = .47).Conclusions: En bloc EMR for colonic lesions ≥ 10 mm is associated with a 6.5% rate of macroscopic residual neoplasia. Although 45% of SSPs had neoplasia extending to the resection margin, rates of residual neoplasia at surveillance colonoscopy were low. These results suggest that when feasible en bloc EMR is a reasonable option to resect SSPs ≥ 10 mm. [ABSTRACT FROM AUTHOR]

Purpose: Patients with locally advanced pancreatic cancer typically have poor outcomes, with a median survival of approximately 16 months. Novel methods to improve outcomes are needed. Nab-paclitaxel (Abraxane) has shown efficacy in pancreatic cancer and is FDA-approved for metastatic disease in combination with gemcitabine. Nab-paclitaxel is also a promising radiosensitizer based on laboratory studies, but it has never been clinically tested with definitive radiotherapy for locally advanced pancreatic carcinoma.Methods: We performed a phase 1 study using a 3 + 3 dose escalation strategy to determine the safety and tolerability of dose-escalated nab-paclitaxel with fractionated radiotherapy for patients with unresectable or borderline resectable pancreatic cancer. Following induction chemotherapy with two cycles of nab-paclitaxel and gemcitabine, patients were treated with weekly nab-paclitaxel and daily radiotherapy to a dose of 52.5 Gy in 25 fractions. Final dose-limiting toxicity (DLT) determination was performed at day 65 after the start of radiotherapy.Results: Nine patients received nab-paclitaxel at a dose level of either 100 mg/m2 (n = 3) or 125 mg/m2 (n = 6). There were no observed grade 3 gastrointestinal toxicities. One DLT (grade 3 neuropathy) was observed in a patient who received 125 mg/m2 of nab-paclitaxel. Other grade 3 toxicities included fatigue (11%), anemia (11%) and neutropenia (11%). No grade 4 toxicities were observed. Following chemoradiotherapy, four patients (borderline resectable, n = 2 and unresectable, n = 2) underwent surgical resection, all with negative margins and with significant treatment effect with limited tumor viability.Conclusions: The combination of fractionated radiation and weekly full dose nab-paclitaxel was safe and well-tolerated. [ABSTRACT FROM AUTHOR]

Background: Radiation therapy for head, neck, and esophageal cancer can result in esophageal strictures that may be difficult to manage. Radiation-induced esophageal strictures often require repeat dilation to obtain relief of dysphagia. This study aimed to determine the long-term clinical success and rates of recurrent and refractory stenosis in patients with radiation-induced strictures undergoing dilation. Methods: Retrospective cohort study of patients with radiation-induced strictures who underwent endoscopic dilation by a single provider from October 2007-October 2012. Outcomes measured included long-term clinical efficacy, interval between sessions, number of dilations, and proportion of radiation strictures that were recurrent or refractory. Risk factors for refractory strictures were assessed. Results: 63 patients underwent 303 dilations. All presented with a stricture >30 days after last radiation session. Clinical success to target diameter was achieved in 52 patients (83 %). A mean of 3.3 (±2.6) dilations over a median period of 4 weeks was needed to achieve initial patency. Recurrence occurred in 17 (33 %) at a median of 22 weeks. Twenty-seven strictures (43 %) were refractory to dilation therapy. Fluoroscopy during dilation (OR 22.88; 95 % CI 3.19-164.07), severe esophageal stenosis (lumen <9 mm) (OR 10.51; 95 % CI 1.94-56.88), and proximal location with prior malignancy extrinsic to the lumen (OR 6.96; 95 % CI 1.33-36.29) were independent predictors of refractory strictures in multivariate analysis. Conclusions: (1) Radiation-induced strictures have a delayed onset (>30 days) from time of radiation injury. (2) Endoscopic dilation can achieve medium-term luminal remediation but the strictures have a high long-term recurrence rate of up to 33 %. (3) Remediation of radiation strictures following laryngectomy can be achieved but require frequent dilations. (4) Clinical and procedural predictors may identify patients at high risk of refractory strictures. (5) The optimal strategy in highly selected refractory patients is not clear. [ABSTRACT FROM AUTHOR]

Objective--To describe techniques for endoscopic retrograde cholangiography (ERC) and endoscopic retrograde biliary stenting of the common bile duct (CBD) for minimally invasive treatment of extrahepatic bile duct obstruction (EHBDO) in dogs. Design--Experimental study and clinical report. Animals--7 healthy research dogs and 2 canine patients. Procedures--ERC and endoscopic retrograde biliary stenting were performed in healthy purpose-bred research dogs and client-owned dogs with a diagnosis of EHBDO that underwent an attempted biliary stent procedure. Research dogs were euthanized after completion of the procedure and underwent necropsy. With dogs under general anesthesia, the pylorus was cannulated with a side-view duodenoscope, and the duodenum was entered. The major duodenal papilla (MDP) and minor duodenal papilla were then identified, and the MDP was cannulated. Endoscopic retrograde cholangiography and endoscopic retrograde biliary stenting were attempted with the aid of endoscopy and fluoroscopy in all dogs. Procedure time, outcome for duodenal and MDP cannulation, and success of stent placement were recorded. Results--Endoscopic retrograde cholangiography was successfully performed in 5 of 7 research dogs and in 1 of 2 patients. Biliary stenting was achieved in 4 of 7 research dogs and 1 of 2 patients, with a polyurethane (n = 4) or self-expanding metallic stent (1). One patient had a mass such that visualization of the MDP was impossible and no attempt at biliary cannulation could be made. After placement, stent patency was documented by means of contrast cholangiography and visualization of biliary drainage into the duodenum intra-operatively. No major complications occurred during or after the procedure in any patient. Follow-up information 685 days after stent placement in 1 patient provided evidence of biliary patency on serial repeated ultrasonography and no evidence of complications. Conclusions and Clinical Relevance--ERC and endoscopic retrograde biliary stenting were successfully performed in a small group of healthy dogs and 1 patient with EHBDO, but were technically challenging procedures. Further investigation of this minimally invasive technique for the treatment of EHBDO in dogs is necessary before this may be considered a viable alternative to current treatment methods. [ABSTRACT FROM AUTHOR]

The article reports on a study which describes the quality indicators for endoscopic ultrasound. The researchers have determined the effectiveness of EUS for the diagnosis and staging of gastrointestinal and mediastinal mass lesions or from tissue or fluid for cytologic and chemical analysis. Findings suggest that quality of health care can be measured by comparing the performance of patients with a benchmark parameter of the effectiveness of EUS techniques.

The article discusses the development and current state of Per-Oral Endoscopic Myotomy (POEM), which is a minimally invasive endoscopic procedure. Topics discussed include the use of POEM for the management of classic achalasia and other hyprtensive motor disorders, POEM in children and elderly people, and complications of the procedure. Also discussed are factors to be considered when training for POEM and for starting a POEM program.

We have developed and optimized a microfluidic device platform for the capture and analysis of circulating pancreatic cells (CPCs) and pancreatic circulating tumor cells (CTCs). Our platform uses parallel anti-EpCAM and cancer-specific mucin 1 (MUC1) immunocapture in a silicon microdevice. Using a combination of anti-EpCAM and anti-MUC1 capture in a single device, we are able to achieve efficient capture while extending immunocapture beyond single marker recognition. We also have detected a known oncogenic KRAS mutation in cells spiked in whole blood using immunocapture, RNA extraction, RT-PCR and Sanger sequencing. To allow for downstream single-cell genetic analysis, intact nuclei were released from captured cells by using targeted membrane lysis. We have developed a staining protocol for clinical samples, including standard CTC markers; DAPI, cytokeratin (CK) and CD45, and a novel marker of carcinogenesis in CPCs, mucin 4 (MUC4). We have also demonstrated a semi-automated approach to image analysis and CPC identification, suitable for clinical hypothesis generation. Initial results from immunocapture of a clinical pancreatic cancer patient sample show that parallel capture may capture more of the heterogeneity of the CPC population. With this platform, we aim to develop a diagnostic biomarker for early pancreatic carcinogenesis and patient risk stratification. [ABSTRACT FROM AUTHOR]

Background: The Fundamentals of Endoscopic Surgery™ (FES) program consists of online materials and didactic and skills-based tests. All components were designed to measure the skills and knowledge required to perform safe flexible endoscopy. The purpose of this multicenter study was to evaluate the reliability and validity of the hands-on component of the FES examination, and to establish the pass score. Methods: Expert endoscopists identified the critical skill set required for flexible endoscopy. They were then modeled in a virtual reality simulator (GI Mentor™ II, Simbionix™ Ltd., Airport City, Israel) to create five tasks and metrics. Scores were designed to measure both speed and precision. Validity evidence was assessed by correlating performance with self-reported endoscopic experience (surgeons and gastroenterologists [GIs]). Internal consistency of each test task was assessed using Cronbach's alpha. Test-retest reliability was determined by having the same participant perform the test a second time and comparing their scores. Passing scores were determined by a contrasting groups methodology and use of receiver operating characteristic curves. Results: A total of 160 participants (17 % GIs) performed the simulator test. Scores on the five tasks showed good internal consistency reliability and all had significant correlations with endoscopic experience. Total FES scores correlated 0.73, with participants' level of endoscopic experience providing evidence of their validity, and their internal consistency reliability (Cronbach's alpha) was 0.82. Test-retest reliability was assessed in 11 participants, and the intraclass correlation was 0.85. The passing score was determined and is estimated to have a sensitivity (true positive rate) of 0.81 and a 1-specificity (false positive rate) of 0.21. Conclusions: The FES hands-on skills test examines the basic procedural components required to perform safe flexible endoscopy. It meets rigorous standards of reliability and validity required for high-stakes examinations, and, together with the knowledge component, may help contribute to the definition and determination of competence in endoscopy. [ABSTRACT FROM AUTHOR]

Background: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have transformed the ability to endoscopically remove superficial lesions throughout the gastrointestinal tract. The purpose of this study was to determine the properties and safety of a novel gel designed for the purpose of submucosal injection for EMR and ESD. Methods: Upper endoscopy was performed in six Yorkshire pigs with 5-8 submucosal injections of varying amounts of Cook Medical (Bloomington, IN) gel were delivered in the stomach of each animal. A submucosal bleb of 1-2 ml normal saline was created followed by subsequent injection of 1-5 ml of the gel. Four animals were immediately euthanized and necropsy was performed after gel delivery and in two pigs; repeat endoscopy was performed after 4 weeks followed by necropsy. Results: Thirty-nine submucosal injections were performed in six pigs. Every injection resulted in adequate mucosal lifting with a shoulder and defined margin and no cases of gel extravasation. Twenty-seven injections were performed in four pigs followed by immediate necropsy. The submucosal cushion was still present at the time of organ extraction without evidence of perforation, bleeding or tissue damage. Unroofing of the mucosal layer demonstrated a clean submucosal tissue dissection without bleeding or tissue damage. Twelve submucosal injections were performed in two pigs, and repeat endoscopy at 4 weeks demonstrated persistent submucosal cushion without evidence of mucosal ischemia or ulceration. Necropsy demonstrated no evidence of perforation, bleeding, or gel extravasation. Unroofing the mucosa confirmed a clean submucosal dissection. The injectate did not result in mesenteric fibroinflammatory reaction, tissue damage, or adhesion formation after 4 weeks. Conclusions: The gel appears to be a safe injectate that provides a submucosal cushion with a duration that is longer than other available injectates for EMR and ESD. The clean submucosal dissection may decrease the length of these procedures while minimizing complications. [ABSTRACT FROM AUTHOR]

The introduction of innovative techniques and novel technologies into clinical practice is a challenge that confronts all aspects of healthcare delivery. Upheaval from shrinking research funding and declining healthcare reimbursements now forces patients, doctors, hospitals, payers, regulators, and even health systems into conflict as new therapies struggle to find a place in the therapeutic armamentarium. The escalating costs of healthcare force all parties to consider both the medical risks/benefits as well as the economic efficiency of proposed tools and therapies. We highlight these challenges by examining the process of initiating and conducting a 'society-as-investigator' clinical trial to assess the safety of the natural orifice translumenal endoscopic surgery (NOTES) approach to cholecystectomy in the context of the issues that confront technology diffusion today. [ABSTRACT FROM AUTHOR]

Purpose: Platinum compounds or bevacizumab, in combination with gemcitabine, achieved good response rates in early studies in advanced pancreatic cancer. This prompted an evaluation of an aggressive approach to allow better local control and resectability in locally advanced disease. Methods: We piloted a combination of gemcitabine/oxaliplatin/bevacizumab Q2w for four cycles, followed by oxaliplatin and bevacizumab added to infusional 5-FU and radiotherapy, in patients with locally advanced pancreatic cancer. Results: Nineteen patients were treated, of whom 17 completed the protocol-specified treatment. Median age was 60 years. Fifteen had unresectable, and four had borderline resectable disease. Toxicity of chemotherapy was moderate: grade III neutropenia (5) and grade I/II nausea, vomiting, fatigue, and neuropathy. During chemoradiation, major grade III toxicities were nausea and vomiting (3 each). One patient had intractable pain early on, necessitating treatment cessation. Response rate for 18 evaluable patients was 11 % (by RECIST); five patients (4 inoperable, 1 borderline, 26 %) went on to have surgery. One-year overall survival was 58 % and progression-free survival was 37 %. Conclusions: This combination, associated with higher response rates in metastatic disease, had a lower than expected response rate in primary tumors. Although tolerable, our approach failed to affect clinical outcomes meaningfully. [ABSTRACT FROM AUTHOR]

The article discusses the second white paper by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy. It mentions that the said white paper provides details on the natural orifice transluminal endoscopic surgery (NOTES) in terms of issues such as in gastric closure, and peritoneal access. Moreover, information on the 2010 International NOTES summit meeting held in Chicago, Illinois on July 7-10, 2010 is presented.

Background: Computer-based endoscopy simulators have been developed to enable trainees to learn and gain technical endoscopic skills before operating on patients. However, these simulators have not been validated as models of patient-based endoscopy. This study aimed to determine whether a computer-based simulator can accurately represent an actual esophagogastroduodenoscopy (EGD) and colonoscopy and to evaluate its ability to discriminate between varying levels of expertise in performing endoscopic procedures based on objective parameters. Methods: In a prospective, observational trial, five first-year gastroenterology fellows and six gastroenterology attendings from a single academic center completed six endoscopy cases on the Simbionix GI Mentor II endoscopy simulator. The cases were selected to represent common clinical scenarios. The performance parameters were collected by the simulator. The 13 performance parameters measured by the endoscopy simulator were compared between the two study groups. After the simulator cases, the participants completed a survey evaluating the realism of the simulator. Results: Novices and experts were able to complete the tasks in the simulated cases with no significant overall differences between the two groups. The computer-based simulator was able to discriminate levels of expertise only for parameters related to the time spent on the procedure (total time, time to reach the second duodenum, time to reach the cecum, and efficiency of screening). No statistically significant differences were found for the other nine performance parameters measured by the simulator. Based on the survey data, expert opinion concluded that the simulator does not offer a realistic simulation of human endoscopy. Conclusions: The computer-based endoscopy simulator displays a lack of ability to discriminate between novices and experts in terms of endoscopic skills based on measured objective performance parameters. The findings of this study suggest that the computer-based simulator lacks fidelity and that upgrades are necessary to increase the simulator's ability to reproduce human endoscopy more accurately. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) has proven to be an effective diagnostic modality for the detection and staging of pancreatic malignancies. In recent years EUS-FNA has also been used to diagnose lesions of non-pancreatic sites such as structures in close proximity to the gut wall within the mediastinum, abdomen, pelvis and retro-peritoneum. Aims: To evaluate experience with EUS-FNA of non-pancreatic sites at a large university medical centre. Methods: The study cohort included 234 patients who underwent EUS-FNA of 246 lesions in non-pancreatic sites (122 peri-pancreatic and coeliac lymph nodes; 9 peri-pancreatic masses; other sites: mediastinum 12, gastric 25, liver 27, oesophagus 17, duodenum/colon/rectum 15, retro-peritoneum 8, lung 7, miscellaneous 4). Results: The cytology diagnoses were classified as non-neoplastic/reactive in 82 (33%), atypical/suspicious for malignancy in 25 (10%), malignant in 86 (35%) and non-diagnostic in 53 (22%) cases. Surgical pathology follow-up was available in 75 (31%) cases. Excluding the non-diagnostic cases there were 7 false negative and 3 false positive cases. The sensitivity, specificity and positive predictive value of EUS-FNA in the diagnosis of lesions of non-pancreatic sites was 92%, 98% and 97%, respectively. Conclusions: EUS-FNA can be effectively used as a diagnostic modality in the diagnosis of lesions from non-pancreatic sites. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Biliary complications and their treatment in adult cadaveric liver transplantation (CLT) are well described. However, biliary complications and their management in living donor liver transplantation (LDLT) are not well characterized. We assessed the role of endoscopic retrograde cholangiopancreatography (ERCP) in the diagnosis and management of biliary complications following LDLT.METHODS: We performed a retrospective cohort analysis of all LDLT recipients with duct-to-duct anastomoses (n= 15). Specific data included referral for ERCP, diagnosis, and therapy. Comparisons were made to a 260 CLT recipient cohort.RESULTS: Greater percentage of LDLT recipients underwent ERCP (73%) compared to CLT recipients (25%;p= 0.001). Biliary complications diagnosed by ERCP in LDLT recipients consisted of bile leaks and strictures, and were more frequent than in CLT recipients (leaks: 53%vs12%;p= 0.001; strictures: 27%vs5%;p= 0.01). Most leaks occurred at T-tube sites (LDLT: 87%; CLT: 65%). Diagnosis and therapy of leaks required a median of 2 ERCP procedures in both groups. Bile leaks were successfully treated endoscopically in 100% and 84% of LDLT and CLT recipients, respectively (p= 0.56). Most biliary strictures were anastomotic (LDLT: 100%; CLT: 64%). Strictures were diagnosed and treated with a median of 1.5 and 2 ERCP procedures in the LDLT and CLT groups, respectively. The duration of endoscopic therapy was a median of 10 and 14 wk, and success rates were 75% and 62% (p= 1.0) in LDLT and CLT groups, respectively.CONCLUSIONS: LDLT is associated with increased biliary complications as compared to CLT. ERCP is useful for diagnosis, can successfully treat most LDLT-related biliary complications, and should be attempted prior to more invasive interventions. [ABSTRACT FROM AUTHOR]

: ObjectivesBiliary casts develop in up to 18% of liver transplant recipients. Casts are associated with morbidity, graft failure, need for retransplantation, and mortality. Proposed etiological mechanisms include acute cellular rejection, ischemia, infection, and biliary obstruction. We aimed to identify clinical features associated with biliary cast formation, review treatments, and analyze the biochemical composition of casts at a single, large, liver transplant center.: MethodsPatient records were reviewed retrospectively to identify patients who developed casts. Data were collected with attention to ischemia, rejection, obstruction, infection, immunosuppression, postoperative biliary drain use, and cast-directed management, and were compared with data from controls. Cast specimens, retrieved at cholangiography, were analyzed with chromatography techniques.: ResultsIschemic factors were noted in 70% (7/10) of cast patients versus 15% (6/40) of controls (OR = 13.2; 95% CI = 2.7–66.0; p = 0.001). Biliary strictures were present in 50% of cast patients versus 10% of controls (OR = 9.0; 95% CI = 1.8–45.2; p = 0.01). Differences in cold ischemia time, acute cellular rejection, cyclosporin use, infection, and postoperative biliary drain use were not significant. Casts were successfully treated by endoscopic and percutaneous methods in 60% of patients. One patient died of cast-related complications (mortality 10%). Four casts were in satisfactory condition for biochemical analysis. Bilirubin was the main component (∼10–50%). Bile acid synthesis products and cholesterol comprised smaller percentages, and protein comprised only 5–10%.: ConclusionBiliary casts are more likely to develop in the setting of hepatic ischemia and biliary strictures. Endoscopic and percutaneous cast extraction might achieve favorable results and should be attempted before surgical therapy. [Copyright &y& Elsevier]

Objective: This study was designed to identify factors that influence primary care physicians' willingness to perform flexible sigmoidoscopy.Measurements: Using a mailed questionnaire, we surveyed all 161 primary care physicians participating in a large health care system. We obtained information on training, current practice patterns, beliefs about screening for colorectal cancer, and the influence of various factors on their decision whether or not to perform flexible sigmoidoscopy in practice.Main Results: Of the 131 physicians included in the analysis, 68 (52%) reported training in flexible sigmoidoscopy, of whom 36 (53%) were currently performing flexible sigmoidoscopy in practice. Time required to perform flexible sigmoidoscopy, availability of adequately trained staff, and availability of flexible sigmoidoscopy services provided by other clinicians were identified most often as reasons not to perform the procedure in practice. Male physicians were more likely than female physicians to report either performing flexible sigmoidoscopy or desiring to train to perform flexible sigmoidoscopy (odds ratio 2.61; 95% confidence interval 1.10, 6.23). This observed difference appears to be mediated through different weighting of decision criteria by male and female physicians.Conclusions: Approximately half of these primary care physicians trained in flexible sigmoidoscopy chose not to perform this procedure in practice. Self-perceived inefficiency in performing office-based flexible sigmoidoscopy deterred many of these physicians from providing this service for their patients. [ABSTRACT FROM AUTHOR]

Background: In 2015, the American Gastroenterological Association (AGA) published guidelines to provide recommendations for management of suspected pancreatic cystic neoplasms (PCNs). The aim of this study was to compare efficacy of these with the Fukuoka consensus guidelines in predicting advanced neoplasia (AN) in patients with suspected PCNs.Study Design: We performed a retrospective study of 239 patients who underwent surgical resection for suspected mucinous PCN at a tertiary care center from 2000 to 2014. Surgical pathology was the gold standard. The AGA and Fukuoka criteria were applied, and their performance in predicting AN, defined as invasive cancer or high-grade dysplasia (HGD), was assessed.Results: Advanced neoplasia was found in 71 of 239 (29.7%) patients (28 invasive cancer, 43 HGD). The Fukuoka "high-risk" (FG-HR) and AGA "high-risk" (AGA-HR) criteria identified patients with AN with sensitivities of 28.2% and 35.2%, specificities of 95.8% and 94.0%, positive predictive values of 74.1% and 71.4%, and negative predictive values of 75.9% and 77.5%, respectively. Overall, there was no significant difference between the guidelines for prediction of AN. There were 7 and 6 cases with invasive cancer, and 23 and 24 cases with HGD missed by the FG-HR and AGA-HR guidelines, respectively.Conclusions: In a retrospective analysis, the AGA guidelines are not superior to the Fukuoka guidelines in identifying AN in suspected PCNs. Both sets of guidelines have fair PPV for detection of AN, which would lead to avoidable resections in patients without AN. Additionally, the high-risk features of both guidelines do not accurately identify all patients with AN. [ABSTRACT FROM AUTHOR]