The timing of recurrence after endoscopic papillectomy.

BACKGROUND: Endoscopic papillectomy (EP) offers a safe and effective method for resection of ampullary adenomas. Data regarding the long-term resolution of adenoma following EP are limited. The aim of this study therefore was to examine the timing of recurrence after EP of ampullary adenomas. METHODS: This was a single-center retrospective study including patients who received EP for ampullary adenomas from 8/2000 to 1/2018. Patients with confirmed complete eradication of adenoma were included in the recurrence analysis with recurrence defined as finding adenomatous histology after 1 negative surveillance endoscopy. Kaplan-Meier estimates were calculated to determine recurrence rates. RESULTS: Of the 165 patients who underwent EP, 136 patients (mean age 61.9, 51.5% female) had adenomatous histology with a mean lesion size of 21.2 mm. A total of 124 (91.2%) achieved complete eradication with a follow-up of 345.8 person-years. Recurrence occurred in 20 (16.1%) patients at a mean of 3.2 (± 3) years (range 0.5-9.75 years) for a recurrence rate of 5.8 (95% CI 3.6-8.8) per 100 person-years. Nine (45%) recurrences occurred after the 1st 2 years of surveillance. Recurrence rate did not differ by baseline pathology [low-grade dysplasia: 5.2 (95% CI 3.0-9.0), high-grade dysplasia: 6.9 (95% CI 2.3-15.5), adenocarcinoma: 7.7 (95% CI 0.9-25.1)]. CONCLUSION: Recurrence remains a significant concern after EP. Given the timing of recurrence, long surveillance periods may be necessary. Larger multicenter studies are needed, however, to determine appropriate surveillance intervals.

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Endoluminal vacuum closure of a duodenal perforation.

Perforation is a known complication of endoscopic resection and has been managed with endoscopic defect closure, antibiotics and close observation. Closure of duodenal perforations are more challenging due to the presence of gastric and pancreaticobiliary secretions. The use of endoluminal vacuum therapy (EVT) to divert flow and aid closure is increasingly prevalent and may avoid high-risk surgery. We describe the use of endoluminal vacuum closure to salvage an iatrogenic duodenal perforation in a 57-year-old male who underwent an endoscopic mucosal resection of a 35-mm polypoid lesion on the posterior wall of the second portion of the duodenum. The endoluminal wound vac successfully controlled leakage and allowed defect closure. EVT is an emerging technique that can effectively manage complicated injuries throughout the GI tract and may allow enhanced recovery by avoiding surgical salvage and its associated morbidity and mortality.

Adverse Events Associated With Therapeutic Endoscopic Retrograde Pancreatography.

OBJECTIVES: Data regarding the safety of endoscopic retrograde pancreatography (ERP) are limited compared with biliary endoscopic retrograde cholangiopancreatography. The aim of this study was to determine adverse events (AEs) associated with therapeutic ERP. METHODS: This single-center retrospective study examined consecutive therapeutic ERPs with the primary intention of cannulating the pancreatic duct. Multivariate logistic regression was performed to identify risk factors for AEs. RESULTS: A total of 3023 ERPs were performed in 1288 patients (mean age, 50.3 years; 57.8% female) from January 2000 to January 2017. Overall AE rate was 18.9% with abdominal pain requiring admission (9.8%) and post-ERP pancreatitis (5.7%) being most common. On multivariate analysis, female sex (adjusted odds ratio [aOR], 2.3; 95% confidence interval [CI], 1.9-2.9), acute recurrent pancreatitis (aOR, 5.0; 95% CI, 1.7-15.3), chronic pancreatitis (aOR, 1.8; 95% CI, 1.3-2.6), and pancreatic sphincter of Oddi dysfunction (aOR, 2.1; 95% CI, 1.4-3.3) were associated with an increased risk of overall AEs. Pancreatic sphincterotomy (aOR, 1.9; 95% CI, 1.5-2.4) and therapeutic stenting (aOR, 1.6; 95% CI, 1.2-2.2) also increased the risk of AEs. CONCLUSIONS: Nearly 1 in 5 patients who undergo therapeutic ERP will experience an AE; however, the rates of major AEs, including post-ERP pancreatitis, bleeding, and perforation, are low.

Combination of ERCP-Based Modalities Increases Diagnostic Yield for Biliary Strictures.

BACKGROUND: Biliary stricture evaluation with brush cytology and intraductal forceps biopsy carries a low sensitivity, but the combination of newer modalities may improve sensitivity. AIM: To determine whether the addition of advanced modalities increases diagnostic yield of ERCP-based sampling. METHODS: This single-center retrospective study evaluates patients with biliary strictures sampled using brush cytology. Operating characteristics were calculated for individual and combinations of modalities including cholangioscopy, fluoroscopy- and cholangioscopy-directed intraductal biopsy, fluorescence in situ hybridization (FISH), and confocal laser endomicroscopy. Analyses under Standard Criteria (SC) included malignant results as "positive" and Expanded Criteria (EC) included "suspicious" and "high-grade dysplasia" results as "positive." RESULTS: A total of 614 patients were included, and 354 (57.8%) received brush cytology alone, which had a sensitivity of 38.5% (SC) to 40.3% (EC) and a specificity of 97.8% (EC) to 99.3% (SC). Combining brush cytology with fluoroscopy-guided biopsy (n = 259, 42.2%) had a sensitivity of 62.5% (SC) to 67.9% (EC) and specificity of 90.2% (EC) to 96.7% (SC). Adding FISH to brush cytology had a sensitivity of 84.2% (SC) to 87.5% (EC) and specificity of 54.1% (SC and EC), while cholangioscopy visualization addition resulted in a sensitivity of 80.4% (SC) to 92.2% (EC) and specificity of 67.3% (EC) to 89.1% (SC). There were no significant differences in sensitivity and specificity using SC and EC. CONCLUSIONS: Brush cytology has a low sensitivity, but the addition of other modalities increases sensitivity. There was no difference in specificity between the SC and the EC, supporting the inclusion of "suspicious" impressions with malignant results at our center.

High prevalence of musculoskeletal symptoms and injuries in third space endoscopists: an international multicenter survey.

Background and study aims Third space endoscopy (TSE), including per-oral endoscopic myotomy and endoscopic submucosal dissection, is technically challenging and physically demanding. The aim of this study was to assess the prevalence and types of musculoskeletal symptoms and injuries (MSI) in third space endoscopists and its impact on clinical practice. Materials, Patients and methods A 22-item survey measuring endoscopist characteristics, procedure volumes, MSI, and its effect on clinical practice was distributed to endoscopists practicing TSE. Descriptive statistics were used to depict MSI. Logistic regression was used to identify predictors for MSI related to TSE. Results The survey was completed by 45 of 110 endoscopists (40.9 %) who received the survey, representing 10 countries across four continents. Thirty-one (69 %) endoscopists reported current MSI with 71 % (n = 22/31) believing these began after starting TSE, and 48.9 % (22/45) reporting more symptoms after TSE compared to endoscopic ultrasound/endoscopic retrograde cholangiopancreatography. Common MSI included the shoulders (42.2 %), back (37.8 %), neck (33.3 %), and wrist (24.4 %). Lower extremity MSI were also reported with foot symptoms (11.1 %) being most common. A minority required disability (2.2 %), change in endoscopy scheduling (6.7 %) or surgery (2.2 %). Only 15.6 % of endoscopists had received prior ergonomics training. Logistic regression revealed no significant predictors for MSI. Conclusions Over two-thirds of endoscopists performing TSE suffer from MSI, with many reporting onset of their symptoms after starting TSE in their practice. Further studies are needed to understand and reduce the risk of MSI in TSE given the growing demand for these procedures and the potential long-term impact of this occupational hazard.

Endoscopic Ultrasound Placement of Preloaded Fiducial Markers Shortens Procedure Time Compared to Back-Loaded Markers.

BACKGROUND & AIMS: Fiducial markers are inert radiopaque gold or carbon markers implanted in or near pancreatic tumor to demarcate areas for image-guided radiation therapy. Endoscopic ultrasound (EUS) pre-loaded fiducial needles (PLNs) have been developed to circumvent technical issues associated with traditional back-loaded fiducials (BLNs). We performed a randomized controlled trial to compare procedure times in patients with pancreatic adenocarcinoma undergoing EUS-guided placement of BLNs vs PLNs. METHODS: In a prospective study, 44 patients with pancreatic adenocarcinoma referred for fiducial marker placement at 2 tertiary care centers were assigned to groups that received PLNs (n = 22) or BLNs (n = 22); each group had the same proportion of patients with tumors of different locations (head or neck vs body or tail).The procedure was standardized among all endoscopists and placement of a minimum of 3 markers inside the tumor was defined as technical success. The times for procedure and fiducial placement were recorded, total number of fiducial markers used documented, and grade of procedure difficulty ranked by passing the needle or deploying the fiducials. Other recorded variables included tumor characteristics, fluoroscopy use, and the number of fiducials clearly seen by EUS and fluoroscopy. The primary aim was to compare the duration of EUS-guided fiducial insertion of BLNs vs PLNs. RESULTS: The median placement time was significantly shorter in the PLN group (9 min) than the BLN group (16 min) (P < .001). However, the 44% reduction in time did not reach pre-specified levels (≥60%). Similar results were found after stratifying by tumor location. Deployment of BLNs was easier than deployment of PLNs (P = .03). There was no significant difference between groups in technical success, number of fiducials placed, EUS or fluoroscopic visualization, or adverse events. During simulation computed tomography and image-guided radiation therapy, there was no difference between groups in visualization of fiducials, migration rate, or accuracy of placement. CONCLUSIONS: In a randomized controlled trial of 44 patients with pancreatic adenocarcinoma, we found EUS-guided placement of PLNs to require less time and produce similar results compared with BLNs. Further refinements in PLN delivery system are needed to increase the ease of deployment. Clinicaltrials.gov no: NCT02332863.

A Comparison of Endoscopic Retrograde Pancreatography With or Without Pancreatoscopy for Removal of Pancreatic Duct Stones.

OBJECTIVES: Pancreatic duct stones contribute to pain in patients with chronic pancreatitis, and per-oral pancreatoscopy (POP) allows visualization, fragmentation, and removal of these stones. This study compared the safety and efficacy of endoscopic retrograde pancreatography (ERP) with and without POP. METHODS: This single-center retrospective review compared ERP with and without POP for treatment of main-duct pancreatic duct stones. The primary outcome was technical success, defined as partial or complete stone removal, which was compared between the 2 groups. RESULTS: In all, 223 patients underwent 549 ERPs with a technical success rate of 92.4% and complete stone clearance rate of 74.9%. Patients undergoing ERP with POP (n = 94) had higher technical success than patients undergoing ERP without POP (n = 129, 98.9% vs 87.6%, P < 0.001), but required more ERPs (3.1 vs 1.9, P = 0.02). Endoscopic retrograde pancreatography with POP was associated with larger stone size (8.9 vs 6.1 mm, P = 0.001), more stones per case (5+ stones: 33.8% vs 21.1%, P = 0.002), and more impacted stones (48.8% vs 10.3%, P < 0.001). CONCLUSIONS: Per-oral pancreatoscopy-guided lithotripsy permits effective stone removal in cases not amenable to standard ERP techniques, including those with larger or more numerous stones.

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.).

A Survey of Expert Practice and Attitudes Regarding Advanced Imaging Modalities in Surveillance of Barrett's Esophagus.

BACKGROUND: Published guidelines do not address what the minimum incremental diagnostic yield (IDY) for detection of dysplasia/cancer is required over the standard Seattle protocol for an advanced imaging modality (AIM) to be implemented in routine surveillance of Barrett's esophagus (BE) patients. We aimed to report expert practice patterns and attitudes, specifically addressing the minimum IDY in the use of AIMs in BE surveillance. METHODS: An international group of BE experts completed an anonymous electronic survey of domains relevant to surveillance practice patterns and use of AIMs. The evaluated AIMs were conventional chromoendoscopy (CC), virtual chromoendoscopy (VC), volumetric laser endomicroscopy (VLE), confocal laser endomicroscopy (CLE), and wide-area transepithelial sampling (WATS3D). Responses were recorded using five-point balanced Likert items and analyzed as continuous variables. RESULTS: The survey response rate was 84% (61/73)-41 US and 20 non-US. Experts were most comfortable with and routinely use VC and CC, and least comfortable with and rarely use VLE, CLE, and WATS3D. Experts rated data from randomized controlled trials (1.4 ± 0.9) and guidelines (2.6 ± 1.2) as the two most influential factors for implementing AIMs in clinical practice. The minimum IDY of AIMs over standard biopsies to be considered of clinical benefit was lowest for VC (15%, IQR 10-29%) and highest for VLE (30%, IQR 20-50%). Compared to US experts, non-US experts reported higher use of CC for BE surveillance (p < 0.001). CONCLUSION: These results should inform benchmarks that need to be met for guidelines to recommend the routine use of AIMs in the surveillance of BE patients.

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.

Prophylactic tracheal intubation for upper GI bleeding: A meta-analysis.

AIM: To evaluate usefulness of prophylactically intubating upper gastrointestinal bleeding (UGIB) patients. METHODS: UGIB results in a significant number of hospital admissions annually with endoscopy being the key intervention. In these patients, risks are associated with the bleeding and the procedure, including pulmonary aspiration. However, very little literature is available assessing the use of prophylactic endotracheal intubation on aspiration in these patients. A comprehensive search was performed in May 2014 in Scopus, CINAHL, Cochrane databases, PubMed/Medline, Embase, and published abstracts from national gastroenterology meetings in the United States (2004-2014). Included studies examined UGIB patients and compared prophylactic intubation to no intubation before endoscopy. Meta-analysis was conducted using RevMan 5.2 by Mantel-Haenszel and DerSimonian and Laird models with results presented as odds ratio for aspiration, pneumonia (within 48 h), and mortality. Funnel plots were utilized for publication bias and I2 measure of inconsistency for heterogeneity assessments. RESULTS: Initial search identified 571 articles. Of these articles, 10 relevant peer-reviewed articles in English and two relevant abstracts were selected to review by two independent authors (Almashhrawi AA and Bechtold ML). Of these studies, eight were excluded: Five did not have a control arm, one was a letter the editor, one was a survey study, and one was focused on prevention of UGIB. Therefore, four studies (N = 367) were included. Of the UGIB patients prophylactically intubated before endoscopy, pneumonia (within 48 h) was identified in 20 of 134 (14.9%) patients as compared to 5 of 95 (5.3%) patients that were not intubated prophylactically (P = 0.02). Despite observed trends, no significant differences were found for mortality (P = 0.18) or aspiration (P = 0.11). CONCLUSION: Pneumonia within 48 h is more likely in UGIB patients who received prophylactic endotracheal intubation prior to endoscopy.

Endoscopic surveillance for gastric ulcers.

OBJECTIVE: Gastric ulcers (GUs) can be caused by a malignancy, and endoscopists are challenged with the question of how to rule out underlying malignancy. Although routine endoscopic surveillance is not advised, it is still overused. The purpose of this study was to explore the practice in our tertiary referral center during the last 3 years. METHODS: We retrospectively reviewed all inpatient and outpatient esophagogastroduodenoscopies (EGDs) that were performed between November 2009 and November 2012 for GUs. Patients with GUs who normally would not undergo biopsy, such as patients who present with bleeding or had stigmata of high-risk bleeding, were excluded. RESULTS: A total of 165 patients were diagnosed between November 2009 and November 2012 as having GUs on EGD. Fifty-two patients were excluded because they presented with bleeding or had GUs that had stigmata of high-risk bleeding. We reviewed the charts of 113 patients and endoscopic surveillance was recommended for 96 (85%). Of those 96 patients, 72 (64%) underwent repeat EGD. In those 72 patients, GU was still present in 9 patients and was completely healed or healing in 63 patients. Only 25 (22%) GUs were biopsied at initial EGD, 23 of which were benign and 2 were adenocarcinomas. No additional malignancy was found on surveillance EGD. CONCLUSIONS: EGD surveillance for GUs is a common practice, although the guidelines discourage such a practice. Our rate of endoscopic surveillance was significantly higher than reported previously (64% vs 25%). In our experience, such a high rate of surveillance did not reveal any additional gastric malignancy. Alternatively, the rate of biopsy of GUs at initial EGD is low (22%), which also reflects endoscopists' preference for endoscopic surveillance.