A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video).

BACKGROUND AND AIMS: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. METHODS: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. RESULTS: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. CONCLUSIONS: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).

Safety and efficacy of self-expanding metal stents for biliary drainage in patients receiving neoadjuvant therapy for pancreatic cancer.

BACKGROUND AND STUDY AIMS: Durable biliary drainage is essential during neoadjuvant therapy (NAT) in patients with pancreatic cancer who present with biliary obstruction. Plastic stents (PS) tend to occlude readily, resulting in delay/interruption of treatment. Our aim was to evaluate the safety and efficacy of self-expanding metal stents (SEMS) for biliary drainage in patients receiving NAT for pancreatic cancer. PATIENTS AND METHODS: From 2009 to 2014, all consecutive patients with resectable pancreatic cancer at one tertiary center had SEMS placed for biliary drainage before NAT was started. Data on biliary drainage efficacy, stent malfunction rates and procedural adverse events were collected. RESULTS: One hundred forty-two consecutive patients with pancreatic cancer (mean age 66 ±â€Š9 SD years; 81 male, 61 female; 67 resectable, 75 borderline resectable) were enrolled. Eight-seven patients (61 %) had prior PS exchanged to SEMS and 55 (39 %) had SEMS placed upfront. Median duration from SEMS placement to the end of NAT/surgery was 111 days (range 44 - 282). During NAT, SEMS malfunction requiring reintervention occurred in 16 patients (11.2 %): tissue ingrowth 11, stent occlusion from food 6, stent migration 3, incomplete expansion 1, "tissue cheese-cutter" effect 1, and cystic duct obstruction 1. On subgroup analysis, no correlation between SEMS malfunction and stage of disease, prior PS, or duration of NAT was found (r 2  = 0.05, P  = 0.34). Presence of SEMS in situ did not affect pancreaticoduodenectomy. CONCLUSION: SEMS provide safe, effective and durable biliary drainage during NAT for pancreas cancer. Previously placed PS can be exchanged for SEMS. SEMS do not require removal prior to surgery.

A Novel Protocol Obviates Endoscope Sampling for Carbapenem-Resistant Enterobacteriaceae: Experience of a Center with a Prior Outbreak.

BACKGROUND: Numerous published outbreaks, including one from our institution, have described endoscope-associated transmission of multidrug-resistant organisms (MDROs). Individual centers have adopted their own protocols to address this issue, including endoscope culture and sequestration. Endoscope culturing has drawbacks and may allow residual bacteria, including MDROs, to go undetected after high-level disinfection. AIM: To report the outcome of our novel protocol, which does not utilize endoscope culturing, to address our outbreak. METHODS: All patients undergoing procedures with elevator-containing endoscopes were asked to permit performance of a rectal swab. All endoscopes underwent high-level disinfection according to updated manufacturer's guidance. Additionally, ethylene oxide (EtO) sterilization was done in the high-risk settings of (1) positive response to a pre-procedure risk stratification questionnaire, (2) positive or indeterminate CRE polymerase chain reaction (PCR) from rectal swab, (3) refusal to consent for PCR or questionnaire, (4) purulent cholangitis or infected pancreatic fluid collections. Two endoscopes per weekend were sterilized on a rotational basis. RESULTS: From September 1, 2015 to April 30, 2016, 556 endoscopy sessions were performed using elevator-containing endoscopes. Prompted EtO sterilization was done on 46 (8.3%) instances, 3 from positive/indeterminate PCR tests out of 530 samples (0.6%). No CRE transmission was observed during the study period. Damage or altered performance of endoscopes related to EtO was not observed. CONCLUSION: In this pilot study, prompted EtO sterilization in high-risk patients has thus far eliminated endoscope-associated MDRO transmission, although no CRE infections were noted throughout the institution during the study period. Further studies and a larger patient sample will be required to validate these findings.

Outcomes of submucosal (T1b) esophageal adenocarcinomas removed by endoscopic mucosal resection.

AIM: To investigate the outcomes and recurrences of pT1b esophageal adenocarcinoma (EAC) following endoscopic mucosal resection (EMR) and associated treatments. METHODS: Patients undergoing EMR with pathologically confirmed T1b EAC at two academic referral centers were retrospectively identified. Patients were divided into 4 groups based on treatment following EMR: Endoscopic therapy alone (group A), endoscopic therapy with either chemotherapy, radiation or both (group B), surgical resection (group C) or no further treatment/lost to follow-up (< 12 mo) (group D). Pathology specimens were reviewed by a central pathologist. Follow-up data was obtained from the academic centers, primary care physicians and/or referring physicians. Univariate analysis was performed to identify factors predicting recurrence of EAC. RESULTS: Fifty-three patients with T1b EAC underwent EMR, of which 32 (60%) had adequate follow-up ≥ 12 mo (median 34 mo, range 12-103). There were 16 patients in group A, 9 in group B, 7 in group C and 21 in group D. Median follow-up in groups A to C was 34 mo (range 12-103). Recurrent EAC developed overall in 9 patients (28%) including 6 (38%) in group A (median: 21 mo, range: 6-73), 1 (11%) in group B (median: 30 mo, range: 30-30) and 2 (29%) in group C (median 21 mo, range: 7-35. Six of 9 recurrences were local; of the 6 recurrences, 5 were treated with endoscopy alone. No predictors of recurrence of EAC were identified. CONCLUSION: Endoscopic therapy of T1b EAC may be a reasonable strategy for a subset of patients including those either refusing or medically unfit for esophagectomy.

Evaluating Adults With Idiopathic Pancreatitis for Genetic Predisposition: Higher Prevalence of Abnormal Results With Use of Complete Gene Sequencing.

OBJECTIVES: In adults with unexplained pancreatitis, the yield of complete gene versus select exosome sequencing on mutation detection and distinguishing clinical characteristics associated with mutations requires clarification. We sought to (1) compare frequency of mutations identified using different techniques and (2) compare clinical characteristics between adults with and without mutations. METHODS: This is a cohort study of adults with unexplained pancreatitis who underwent genetic testing between January 2008 and December 2012. We compare probabilities of having a positive mutation with complete gene sequencing versus alternatives and describe differences in characteristics among patients with and without mutations. RESULTS: Of the 370 patients, 67 (18%) had a genetic mutation; 24 (6%) were of high risk. Mutations were significantly more prevalent with use of complete sequencing (42%) versus other approaches (8%, P < 0.0001). Most (44/67, 66%) with a mutation had no family history. Those with high-risk mutations were more likely to have a family history of chronic pancreatitis (21% vs 4%, P = 0.002). Patients with pancreas divisum were more likely to have mutations (27% vs 14%, P = 0.0007). CONCLUSION: Among individuals with adult-onset pancreatic disease, the probability of finding any mutation, including high risk, is significantly higher using complete gene sequencing. The impact on patients and providers requires further investigation.

Do larger periprocedural fluid volumes reduce the severity of post-endoscopic retrograde cholangiopancreatography pancreatitis?

OBJECTIVE: Fluid therapy is a cornerstone of the early treatment of acute pancreatitis (AP), but data are conflicting on whether it affects disease severity. Administering greater fluid volumes (FVs) during induction of experimental AP preserves pancreatic perfusion and reduces severity but does not prevent onset of AP. We hypothesized that administering larger FV during endoscopic retrograde cholangiopancreatography (ERCP) associates with less severe post-ERCP pancreatitis (PEP). METHODS: In a retrospective cohort study, we identified 6505 patients who underwent 8264 ERCPs between January 1997 and March 2009; 211 of these patients developed PEP (48 mild, 141 moderate, and 22 severe). Data for FVs were available for 173 patients with PEP. RESULTS: In univariable analysis, only 1 of 16 variables was significantly associated with moderate to severe PEP--larger periprocedural FV was protective (0.94 T 0.3 L vs 0.81 T 0.4 L; P = 0.0129). Similarly,multivariable analysis of moderate to severe PEP identified 1 independent predictor-- larger periprocedural FV was protective (odds ratio, 0.20; 95% confidence interval, 0.05-0.83). Conversely, moderate to severe disease correlated with larger FV administered after PEP diagnosis(reflecting treatment decisions). CONCLUSIONS: This hypothesis-generating study suggests that administering larger periprocedural FVs is protective against moderate to severe PEP. Prospective studies on this topic are warranted.

Treatment of esophageal leaks, fistulae, and perforations with temporary stents: evaluation of efficacy, adverse events, and factors associated with successful outcomes.

BACKGROUND: Factors associated with successful endoscopic therapy with temporary stents for esophageal leaks, fistulae, and perforations (L/F/P) are not well known. OBJECTIVES: To evaluate the safety, efficacy, and outcomes of esophageal stenting in these patients and identify factors associated with successful closure. DESIGN: Retrospective. SETTING: Academic tertiary referral center. PATIENTS: All patients with attempted stent placement for esophageal L/F/P between January 2003 and May 2012. INTERVENTION: Esophageal stent placement and removal. MAIN OUTCOME MEASUREMENTS: Factors predictive of therapeutic success defined as complete closure after index stent removal (primary closure) or after further endoscopic stenting (secondary closure). RESULTS: Sixty-seven patients with 132 attempted stents for esophageal L/F/P were considered; 13 patients were excluded. Among the remaining 54 patients, 117 stents were placed for leaks (29 patients; 64 stents), fistulae (15 patients; 36 stents), and perforations (10 patients; 17 stents). Procedural technical success was achieved in all patients (100%). Primary closure was successful in 40 patients (74%) and secondary closure in an additional 5 (83% overall). On short-term (<3 months) follow-up, 27 patients (50%) were asymptomatic, whereas 22 (41%) had technical adverse events, including stent migration in 15 patients (28%). Factors associated with successful primary closure include a shorter time between diagnosis of esophageal L/F/P and initial stent insertion (9.03 vs 22.54 days; P = .003), and a smaller luminal opening size (P = .002). LIMITATIONS: Retrospective, single-center study. CONCLUSIONS: Temporary stents are safe and effective in treating esophageal L/F/P. Defect opening size and time from diagnosis to stent placement appear to be candidate predictors for successful closure.

Bannayan Ruvalcaba Riley Syndrome.

A 63-year-old male with history of prostate cancer treated with radiation presented for a colonoscopy for small volume hematochezia. The colonoscopy revealed numerous polyps, which were found to be ganglioneuromas on histological examination. He was referred to medical genetics with suspicion for hamartomatous polyposis syndrome and was found to have a mutation in the PTEN gene. Based on this and suggestive clinical findings, he was diagnosed with Bannayan Ruvalcaba Riley syndrome.

ERCP via gastrostomy vs. double balloon enteroscopy in patients with prior bariatric Roux-en-Y gastric bypass surgery.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is the most common bariatric surgery. The performance of ERCP in bariatric RYGB is challenging due to the long Roux limb. We herein compared the indications and technical outcomes of ERCP via percutaneous gastrostomy (GERCP) and double balloon enteroscopy (DBERCP) for patients with prior bariatric RYGB anatomy. METHODS: Between December 2005 and November 2011, consecutive ERCP patients who had undergone RYGB were identified using a prospectively maintained electronic ERCP database. Medical records were abstracted for ERCP indications and outcomes. In most cases, the gastrostomy was done by either laparoscopic or open surgery and allowed to mature at least 1 month before performing ERCP. The choice of route for ERCP was at discretion of managing physician. RESULTS: Forty-four patients (F = 42) with GERCP and 28 patients (F = 26) with DBERCP were identified. The mean age was younger in GERCP than DBERCP (44.8 vs. 56.1, p < 0.001). GERCP patients were more likely to have suspected sphincter of Oddi dysfunction (77 %) as the primary indication whereas DBERCP was suspected CBD stone (57 %). The mean total number of sessions/patient in GERCP and DBERCP was 1.7 ± 1.0 and 1.1 ± 0.4, respectively (p = 0.004). GERCP access to the major papilla was successful in all but two (97 %), whereas duct cannulation and interventions were successful in all. In DBERCP, the success rate of accessing major papilla, cannulation and therapeutic intervention was 78, 63, 56 %, respectively. There was one (3.1 %) post-ERCP pancreatitis in DBERCP. Complications occurred in 11 GERCP procedures (14.5 %) and 10 were related to the gastrostomy. This was significantly higher than that of DBERCP (p = 0.022). CONCLUSIONS: GERCP is more effective than DBERCP in gaining access to the pancreatobiliary tree in patients with RYGB, but it is hindered by the gastrostomy maturation delay and a higher morbidity. Technical improvements in each method are needed.

Impact of a quarterly report card on colonoscopy quality measures.

BACKGROUND: Colonoscopy quality is operator-dependent. Studies assessing the effect of interventions to decrease variation in colonoscopy quality have shown inconsistent results. Since 2009, endoscopists at our university-affiliated, Veterans Affairs medical center have received a quarterly "report card" summarizing individual colonoscopy quality indicators as part of an ongoing quality assurance program. OBJECTIVE: To determine the effect of the quality report card intervention on colonoscopy performance. DESIGN: Retrospective study. SETTING: Tertiary-care, academic, university-affiliated, Veterans Affairs medical center in Indianapolis, Indiana. PATIENTS: Data from 6 endoscopists practicing at the Roudebush Veterans Affairs Medical Center were included. Patients were average-risk, aged 50 years or older, undergoing their first screening colonoscopy. INTERVENTION: Quarterly report card. The study time frame was July 1, 2008 to December 31, 2008 (before-intervention) and April 1, 2009 to March 31, 2011 (intervention). MAIN OUTCOME MEASUREMENTS: The primary outcomes were cecal intubation and adenoma detection rates (ADR), adjusted for physician, patient age, and sex. Multivariable logistic regression was performed to determine factors associated with adenoma detection. RESULTS: A total of 928 patients (male 93%, white 78%) were included (before-intervention 336; intervention 592). There were no significant differences in patient age, sex, smoking status, body mass index, bowel preparation quality, colonoscope model, and proportion of colonoscopies performed with a trainee between the before-intervention and intervention phases. In the intervention phase, the adjusted adenoma detection and cecal intubation rates were significantly higher: 53.9% (95% confidence interval [CI], 49.7%-58.1%) vs 44.7% (95% CI, 39.1%-50.4%); P = .013 and 98.1% (95% CI, 96.7%-99.0%) vs 95.6% (95% CI, 92.5%-97.5%); P = .027, respectively. A higher ADR trend in the intervention phase was found for 5 of the 6 physicians. The increment in ADR was due mostly to increased detection of proximal adenomas. There were no significant changes in serrated polyp detection, advanced neoplasm detection, number of adenomas detected per colonoscopy, and mean size of adenomas after implementation of the intervention. The report card intervention remained significantly associated with higher ADRs after adjustment for patient age, sex, and physician (odds ratio 1.45; 95% CI, 1.08-1.94). LIMITATIONS: Single center, small number of endoscopists. CONCLUSION: A quarterly report card was associated with improved colonoscopy quality indicators. This intervention is practical to generate and implement and may serve as a model for quality improvement programs in different patient and physician groups.

Risk models for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP): smoking and chronic liver disease are predictors of protection against PEP.

OBJECTIVES: We investigated which variables independently associated with protection against or development of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) and severity of PEP. Subsequently, we derived predictive risk models for PEP. METHODS: In a case-control design, 6505 patients had 8264 ERCPs, 211 patients had PEP, and 22 patients had severe PEP. We randomly selected 348 non-PEP controls. We examined 7 established- and 9 investigational variables. RESULTS: In univariate analysis, 7 variables predicted PEP: younger age, female sex, suspected sphincter of Oddi dysfunction (SOD), pancreatic sphincterotomy, moderate-difficult cannulation (MDC), pancreatic stent placement, and lower Charlson score. Protective variables were current smoking, former drinking, diabetes, and chronic liver disease (CLD, biliary/transplant complications). Multivariate analysis identified seven independent variables for PEP, three protective (current smoking, CLD-biliary, CLD-transplant/hepatectomy complications) and 4 predictive (younger age, suspected SOD, pancreatic sphincterotomy, MDC). Pre- and post-ERCP risk models of 7 variables have a C-statistic of 0.74. Removing age (seventh variable) did not significantly affect the predictive value (C-statistic of 0.73) and reduced model complexity. Severity of PEP did not associate with any variables by multivariate analysis. CONCLUSIONS: By using the newly identified protective variables with 3 predictive variables, we derived 2 risk models with a higher predictive value for PEP compared to prior studies.