Use of lumen-apposing metal stents in treating gastrojejunal anastomotic strictures in bariatric patients.

BACKGROUND: Gastrojejunal strictures (GJS) are rare but significant adverse events following Roux-en-Y Gastric Bypass, with limited options for effective non-operative interventions. Lumen-apposing metal stents (LAMS) represent a new therapy for treatment of intestinal strictures, but the effectiveness in treating GJS is unknown. This study aims to evaluate the safety and effectiveness of LAMS in GJS. METHODS: This is a prospective, observational study of patients with prior Roux-en-Y Gastric bypass who underwent LAMS placement for GJS. The primary outcome of interest is resolution of GJS following LAMS removal defined by toleration of bariatric diet after LAMS removal. Secondary outcomes include need for additional procedures, LAMS-related adverse events, and need for revisional surgery. RESULTS: Twenty patients were enrolled. The cohort was 85% female with median age of 43. 65% had marginal ulcers associated with the GJS. Presenting symptoms included nausea and vomiting (50% of patients), dysphagia (50%), epigastric pain (20%), and failure to thrive (10%). Diameter of LAMS placed were 15 mm in 15 patients, 20 mm in 3 patients, and 10 mm in 2 patients. LAMS were placed for a median of 58 days (IQR 56-70). Twelve patients (60%) achieved resolution of GJS after LAMS removal. Of the eight patients without GJS resolution or with recurrence, seven (35%) required repeat placement of LAMS. One patient was lost to follow up. One perforation and two migrations occurred. Four patients required revisional surgery after LAMS removal. CONCLUSION: LAMS placement is well-tolerated and effective with most patients achieving short-term symptom resolution and with few reported complications. While stricture resolution occurred in over half the patients, nearly 1/4th of patients required revisional surgery. More data is needed to predict who would benefit from LAMS versus surgical intervention.

Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts.

BACKGROUND & AIMS: It is a challenge to accurately assess pancreatic cystic lesions (PCLs) and determine their risk. We compared the yield of tissue acquired with endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA), and the accuracy of analyses of each sample type in the diagnosis of mucinous PCLs. METHODS: We performed a prospective open-label study of 114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018. Samples were collected from each cyst by FNA and microforceps; samples collected by FNA were analyzed by cytology and samples collected by TTNB were analyzed by histology. Acquisition yield was defined as the percentage of specimens collected that were adequate for cytologic or histologic analysis. Diagnoses of mucinous cysts were made based on identification of pancreatic mucinous epithelium by cytology analysis of FNA samples or histologic analysis of TTNB samples. Surgical specimens were used as the reference standard when available. RESULTS: The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs. Tissue acquisition yield was significantly higher with TTNB (95 of 114; 83.3%) than FNA (43 of 114; 37.7%) (P < .001). Sixty-one PCLs were determined to be mucinous based on TTNB analysis (53.5%) vs 11 with FNA analysis (9.6%) (P < .001). Among PCLs categorized as equivocal, based on the level of carcinoembryonic antigen, TTNB analysis found 50% (41 of 82) to be mucinous and FNA analysis found 8.5% (7 of 82) to be mucinous (P < .001). Findings from analyses of samples collected by TTNB were 100% concordant with findings from histologic analysis of surgical specimens (14 of 14), whereas only 3 of 14 findings from analysis of samples collected by FNA were in agreement with findings from surgical specimens (21.4%) (P < .001). Four of 5 mucinous PCLs with advanced neoplasia (80%) were detected with TTNB compared with none with FNA (P = .04). Self-limited intracystic bleeding occurred in 7 patients (6.1%), and acute pancreatitis in 6 patients (5.3%). CONCLUSIONS: In a multicenter prospective study of patients undergoing EUS-FNA for evaluation of PCLs, we found TTNB collection of tissues for histologic analysis to be safe and feasible, with an acquisition yield of 83.3%. Histologic analysis of samples collected by TTNB identified a larger proportion of mucinous PCLs compared with cytologic analysis of samples collected by FNA-even among samples categorized as equivocal, based on the level of carcinoembryonic antigen. More samples collected by TTNB than FNA were found to have advanced neoplasia. Clinicaltrials.gov no: NCT02979509.

Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Lymph node metastasis in early gastric adenocarcinoma in the United States of America.

BACKGROUND AND STUDY AIMS: Localized approaches are being increasingly used in the management of early gastric adenocarcinoma; however, there are limited data on lymph node metastasis in the US population. This study examined the incidence and predictors of lymph node involvement for early-stage gastric adenocarcinomas in the USA. PATIENTS AND METHODS: Data were abstracted from the national SEER database from 2004 to 2013. Exclusion criteria included: cases with unknown tumor characteristics, unknown patient characteristics, metastatic disease, neoadjuvant radiation, and lack of surgical resection or lymph node evaluation. Univariate and multivariable analyses were conducted to assess the relationship of tumor stage, grade, and size, and patient sex, race, and age with nodal involvement. RESULTS: 43 769 cases of gastric adenocarcinoma were initially abstracted. After exclusions, 1577 patients remained for analysis. Multivariable analysis revealed that tumor stage (P < 0.001), grade (P = 0.008), and size (P < 0.001) were independent predictors of nodal metastasis. For low grade T1a tumors, nodal metastasis was present in 1.7 %, 1.7 %, 4.5 %, 4.1 %, and 20 % of tumors 0 - 1 cm, 1 - 2 cm, 2 - 3 cm, 3 - 4 cm, and ≥ 4 cm in size, respectively (P < 0.001), and in 8.4 %, 18.0 %, 19.5 %, 22.0 %, and 35.8 % of T1b tumors, respectively (P < 0.001). CONCLUSIONS: Low grade T1a tumors < 4 cm in size have low rates of nodal metastasis in the US population and may warrant consideration for local resection. Larger, higher grade T1b tumors have high rates of nodal metastasis in the US population and lymph node dissection may be indicated for patients who are surgical candidates.

Treatment allocation in patients with early-stage esophageal adenocarcinoma: Prevalence and predictors of lymph node involvement.

BACKGROUND: In considering treatment allocation for patients with early esophageal adenocarcinoma, the incidence of lymph node metastasis is a critical determinant; however, this has not been well defined or stratified by the relevant clinical predictors of lymph node spread. METHODS: Data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute were abstracted from 2004 to 2010 for patients with early-stage esophageal adenocarcinoma. The incidence of lymph node involvement for patients with Tis, T1a, and T1b tumors was examined and was stratified by predictors of spread. RESULTS: A total of 13,996 patients with esophageal adenocarcinoma were evaluated. Excluding those with advanced, metastatic, and/or invasive (T2-T4) disease, 715 patients with Tis, T1a, and T1b tumors were included. On multivariate analysis, tumor grade (odds ratio [OR], 2.76; 95% confidence interval [95% CI], 1.58-4.82 [P<.001]), T classification (OR, 0.47; 95% CI, 0.24-0.91 [P =.025]), and tumor size (OR, 2.68; 95% CI, 1.48-4.85 [P = .001]) were found to be independently associated with lymph node metastases. There was no lymph node spread noted with Tis tumors. For patients with low-grade (well or moderately differentiated) tumors measuring <2 cm in size, the risk of lymph node metastasis was 1.7% for T1a (P<.001) and 8.6% for T1b (P = .001) tumors. CONCLUSIONS: For patients with low-grade Tis or T1 tumors measuring ≤2 cm in size, the incidence of lymph node metastasis appears to be comparable to the mortality rate associated with esophagectomy. For highly selected patients with early esophageal adenocarcinomas, the results of the current study support the recommendation that local endoscopic resection can be considered as an alternative to surgical management when followed by rigorous endoscopic and radiographic surveillance. Cancer 2016;122:2150-7. © 2016 American Cancer Society.

Increased mortality in patients with alcohol-induced pancreatitis during the COVID-19 pandemic.

Background: COVID-19 pandemic affected millions of people worldwide. Alcohol consumption increased during the pandemic, leading to rising numbers of cases of alcohol-related pancreatitis. We aimed to assess the mortality of alcohol-induced pancreatitis during the COVID-19 pandemic in the United States. Methods: We analyzed the National Vital Statistical System's (NVSS) provisional multiple causes of death data, provided by the Centers for Disease Control and Prevention, to assess the mortality of alcohol-induced pancreatitis during the pandemic. Patients with alcohol-induced pancreatitis as a cause of death were analyzed between 2018 and 2021. Patient demographics such as age, sex, ethnicity, and location were studied. Results: During 2018-2021, there were 2547 deaths from alcohol-induced pancreatitis. The total cases and age-adjusted rates of alcohol-induced pancreatitis per 100,000 were similar in 2018 (n=515) and 2019 (n=501) (crude rate=0.1). The number increased to 747 in 2020 and 784 in 2021 (crude rate=0.2). A statistically significant increase in mortality rates was noted in all age groups except 75-84. An increase in mortality in both males and females was noted (48% increase and 64% increase, respectively, P<0.001). The number of deaths increased in both Hispanics (59%, P<0.001) and non-Hispanics (48%, P<0.001). Conclusions: Our analysis demonstrated a substantial increase in the mortality of patients with alcohol-induced pancreatitis during the first 2 years of the COVID-19 pandemic. The increase in alcohol consumption and the burden on mental health caused massive collateral damage to society. Urgent public health interventions are needed at state and national levels to prevent further rise in cases.

Epidemiology of early esophageal adenocarcinoma.

BACKGROUND/AIMS: Endoscopic resection has become the preferred treatment approach for select early esophageal adenocarcinoma (EAC); however, the epidemiology of early stage disease has not been well defined. METHODS: Surveillance Epidemiology and End Results (SEER) data were analyzed to determine age-adjusted incidence rates among major epithelial carcinomas, including EAC, from 1973 to 2017. The percent change in incidence over time was compared according to tumor subtype. Early T-stage, node-negative EAC without metastasis was examined from 2004 to 2017 when precise T-stage data were available. RESULTS: The percent change in annual incidence from 1973 to 2017 was 767% for EAC. Joinpoint analysis showed that the average annual percent change in EAC from 1973 to 2017 was 5.11% (95% confidence interval, 4.66%-5.56%). The annual percent change appeared to plateau between 2004 and 2017; however, early EAC decreased from 2010 to 2017, with an annual percent change of -5.78%. CONCLUSION: There has been a 7-fold increase in the incidence of EAC, which was significantly greater than that of the other major epithelial malignancies examined. More recently, the incidence of early EAC has been decreasing. Approximately one in five patients has node negative, potentially resectable early stage disease.

Enteral Stents for Malignant Gastric Outlet Obstruction: Low Reintervention Rates for Obstruction due to Pancreatic Adenocarcinoma Versus Other Etiologies.

BACKGROUND AND AIM: Enteral stents (ES) have emerged as first-line therapy for the treatment of malignant gastric outlet obstruction (GOO). Stent occlusion arising from tissue ingrowth may require endoscopic or surgical reintervention. The objective of this study was to compare rates of reintervention following palliative ES for patients with GOO due to pancreatic adenocarcinoma (PDAC) versus other malignant etiologies. METHODS: Patients who had undergone ES for palliation of malignant GOO between 2009 and 2018 were retrospectively identified and demographic, clinical, and procedural data were collected. Primary outcome was procedural reintervention for recurrent symptomatic GOO following ES placement. RESULTS: Forty-three patients were included in the study cohort. 62.8% (27/43) of patients had PDAC while 37.2% (16/43) of patients had other malignant etiologies. 11.6% (5/43) of patients were alive at follow-up. Thirty-day and 90-day mortality rates were 22.8% and 70.7% for PDAC and 25% and 56.3% for other malignant etiologies, respectively. Seven patients required reintervention for symptomatic GOO: 14.3% (1/7) had PDAC and 85.7% (6/7) had GOO due to other malignancy (P < .01). Ninety-six percent (26/27) of patients with PDAC required no further intervention for GOO prior to death or end of follow-up. On multivariate analysis, patients with PDAC were significantly less likely to require reintervention than patients with other malignant etiologies (OR 0.064, 95% CI 0.01-0.60). CONCLUSION: ES offer durable symptom palliation without requirement for reintervention for the overwhelming majority of patients with malignant GOO due to PDAC. Reintervention rates are higher following ES placement for GOO due to other malignant etiologies and future study may be needed to define the optimal palliative intervention for this group of patients.

Endoscopic plastic stent therapy for bile leaks following total vs subtotal cholecystectomy.

Background and study aims Plastic biliary stents are standard therapy for treatment of post-cholecystectomy bile leaks. An increasing proportion of patients now undergo subtotal cholecystectomy and are at perceived risk for high-grade bile leak. Data are limited regarding the optimal endoscopic therapy following subtotal cholecystectomy. The aim of this study was to compare outcomes of endoscopic plastic stent therapy for treatment of bile leak following total vs subtotal cholecystectomy. Patients and methods A retrospective cohort of patients with bile leak following cholecystectomy and treated with biliary stent was identified from an institutional database. Primary outcome was defined as cholangiographic resolution of leak at follow-up endoscopic retrograde cholangiopancreatography (ERCP). Results Sixty-one subjects met study inclusion criteria, 27 following total cholecystectomy and 34 following subtotal cholecystectomy. A single plastic biliary stent was placed in 87 % of subjects (53/61), while a fully covered self-expanding metal stent (FCSEMS) was placed in 13 % (8/61). Leak resolution was evident at first follow-up ERCP in 96 % of subjects (26/27) who had undergone total cholecystectomy and 91 % of subjects (31/34) who had undergone subtotal cholecystectomy ( P  = 0.25). Among subjects who had received a plastic stent at index ERCP, leak resolution was evident at first follow-up ERCP in 96 % (23/24) of those who had undergone total cholecystectomy and 90 % (26/29) of those who had undergone subtotal cholecystectomy ( P  = 0.62). Conclusions High rates of leak resolution can be achieved with placement of a single plastic biliary stent for treatment of post-cholecystectomy bile leaks, including after subtotal cholecystectomy.

Mucinous cystic neoplasm diagnosed by EUS-guided microforceps biopsy.

Background and study aims Mucinous cystic neoplasms (MCNs) of the pancreas have malignant potential. Current methods for diagnosing MCNs are inadequate. The aim of this case series is to present a novel method for establishing the diagnosis of MCNs. Clinical information from three patients seen at our institution was collected for a case series presentation. Patients were selected retrospectively based on diagnostic results. Three patients were diagnosed with MCNs based on histopathology obtained via microforceps biopsy. Evolving tissue acquisition techniques, such as microforceps intracystic biopsy, have improved the diagnostic yield of endoscopic ultrasound (EUS).

Incidence, Survival, and Predictors of Lymph Node Involvement in Early-Stage Gastric Signet Ring Cell Carcinoma in the US.

INTRODUCTION: The incidence, survival, and propensity for nodal metastasis in early-stage gastric signet ring cell carcinoma have not been defined in the United States. These data are critical determinants for treatment allocation. METHODS: Cases of gastric signet ring cell carcinoma were extracted from the national SEER database for the years 2004-2013. Age-standardized incidence was derived. Survival was calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed to identify predictors of nodal metastasis. Exclusion criteria included neoadjuvant radiotherapy and lack of histologic or nodal data. RESULTS: A total of 10,624 cases were initially identified. The analysis cohort included 506 cases with early T-stage N0M0 disease following exclusions. The incidence was 0.094 per 100,000 person-years. The 5-year survival rate was 82.8%. Tumor stage (p < 0.001) and size (p < 0.001) were independent predictors of nodal metastasis. The incidence of nodal involvement for T1a tumors <2 cm was 5.4% (p < 0.004). CONCLUSION: The incidence of potentially resectable signet ring gastric carcinoma has not changed significantly over the past decade. While presenting with predominantly high-grade histology, early T-stage disease has a high survival rate. Small T1a tumors have low rates of nodal metastasis, suggesting that an endoscopic resection could be considered in this subset.

Cannulation time is a more accurate measure of cannulation difficulty in endoscopic retrograde cholangiopancreatography than the number of attempts.

BACKGROUND: Cannulation of the common bile duct (CBD) is the initial and sometime challenging step in endoscopic retrograde cholangiopancreatography (ERCP) procedure. Endoscopists often use cannulation attempts and cannulation time to grade cannulation difficulty, but a standard system has yet to be established. The objective of this study was to compare cannulation times with numbers of cannulation attempts, as measures of cannulation difficulty. METHODS: We conducted a prospective study in a tertiary referral center, enrolling 58 patients who were undergoing ERCP for a variety of indications. Cannulation time and the number of cannulation attempts were recorded for each patient. A subset of 14 ERCPs had two observers assessing attempts at cannulation. Cannulation time, number of attempts and inter-observer variability in assessment of attempts were compared and studied. RESULTS: The degree of agreement between two the methods (cannulation times and number of cannulation attempts) was unacceptable. There were considerable discrepancies between attempt tallies from two observers but the mean difference was statistically insignificant. CONCLUSION: The grade of cannulation difficulty for a given ERCP procedure may differ when different methods are used (total cannulation time vs number of attempts); thus, grading by different methods should not be used interchangeably. Cannulation time is a more objective and more accurate assessment tool for grading cannulation difficulty than the number of attempts to cannulate the papilla.