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.

Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.

BACKGROUND AND AIMS: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. METHODS: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. RESULTS: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). CONCLUSIONS: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.

BACKGROUND AND AIMS: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol. METHODS: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed. RESULTS: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006). CONCLUSIONS: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.).

Inspection of endoscope instrument channels after reprocessing using a prototype borescope.

BACKGROUND AND AIMS: Visual inspection of the instrument channel has been proposed as a quality assurance step during endoscope reprocessing. However, the nature and severity of findings in a broad array of endoscopes (gastroscopes, colonoscopes, duodenoscopes, and echoendoscopes) after systemic implementation of an inspection protocol remain unknown. In addition, a study using borescope inspection in upper endoscopes and colonoscopes raised concerns about persistent simethicone residue despite full reprocessing. METHODS: A pilot inspection study using a prototype borescope (SteriCam Inspection Scope; SteriView Inc, San Rafael, Calif) was performed on routinely used endoscopes after high-level disinfection, manual forced-air dry of the instrument channel, and overnight vertical storage. Video recordings 1.5 to 2 minutes in duration were reviewed for visible moisture, debris, discoloration, scratches, channel shredding (scratches that result in strips or filaments of the channel lining protruding into the lumen), and visible evidence of biofilm or simethicone residue. RESULTS: A total of 97 inspections of 59 endoscopes were reviewed. The most common finding was scratches, seen in 51 devices (86%). Channel shredding was found in 35 devices (59%). Intrachannel debris was identified in 22 (23%) of the 97 inspections. No moisture was seen (0%) in the 74 inspections performed after forced-air dry and overnight vertical storage compared with moisture in 5 of 18 inspections (28%) performed after storage alone. No visual evidence of biofilm or simethicone residue was discovered despite its frequent use in our unit. CONCLUSION: Internal defects of the instrument channel appear to occur frequently. Manual forced-air drying of the channel appears to be highly effective in eliminating moisture compared with overnight hang drying alone. Video inspection of the endoscope channel may be useful to audit reprocessing performance and to identify damaged endoscopes.

Duodenoscope reprocessing practice patterns in U.S. endoscopy centers: a survey study.

BACKGROUND AND AIMS: After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing 1 or more of 4 enhanced reprocessing measures in addition to updated manual cleaning methods and high-level disinfection (HLD). The implementation of these techniques in endoscopy facilities and provider opinions regarding reprocessing priorities remain unknown. METHODS: Physicians, nurse managers, nurses, and infection control staff at endoscopy units performing ERCP in the United States were surveyed to assess current institutional practices and individual opinions regarding future reprocessing solutions. RESULTS: A total of 249 distinct institutions participated in the survey. Of these, 223 (89.6%) implemented at least 1 of the 4 supplemental reprocessing methods after MDRO outbreaks. Overall, 63% of centers used repeat HLD, 53% performed surveillance microbiological culturing, 35% used liquid chemical sterilization, and 12% used ethylene oxide sterilization. Thirty-seven centers (15%) routinely screened patients for MDRO. Forced-air drying after reprocessing was used by 47.8% of centers. Fifty percent of individual respondents, including 58.6% of physicians, believed that redesign of the duodenoscope is the best long-term reprocessing solution. The majority (55.1%) identified efficacy to be the single most important factor in selecting a reprocessing technique. CONCLUSIONS: Although most endoscopy centers have implemented enhanced duodenoscope reprocessing techniques, there is a large variation in practice. Most providers believe that duodenoscope redesign and identifying reprocessing techniques with maximal efficacy are the long-term priorities. Improved adherence to forced-air drying in duodenoscope reprocessing is needed.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

High Glasgow Blatchford Score at admission is associated with recurrent bleeding after discharge for patients hospitalized with upper gastrointestinal bleeding.

BACKGROUND AND STUDY AIMS: Upper gastrointestinal bleeding (UGIB) is associated with significant morbidity. The Glasgow Blatchford Score (GBS) can predict endoscopic intervention and in-hospital death, but the ability to predict post-discharge outcomes is unknown. The aims of the study were to determine whether the admission GBS is associated with post-discharge rebleeding and 30-day readmission following hospitalization for UGIB. PATIENTS AND METHODS: In this prospective, observational, cohort study, consecutive patients who were hospitalized with UGIB were enrolled. Admission GBS scores were calculated, and patients with GBS > 7 were classified as high risk. Patients were contacted 30 days following discharge to determine: 1) rate of hospital readmission due to rebleeding, 2) all-cause readmissions, and 3) mortality. Multivariable Cox regression was used to determine associations between GBS, rebleeding, and readmission. RESULTS: A total of 336 patients with UGIB were identified. Patients with high risk GBS were older (68 vs. 62 years; P = 0.01), and were more likely to receive blood (85 % vs. 39 %; P < 0.01) and require intensive care unit admission (64 % vs. 50 %; P = 0.02). Of the 309 patients who survived to discharge, 61 (20 %) were readmitted within 30 days, 25 (8 %) of whom had rebleeding. On multivariable analysis adjusting for the need for endoscopic intervention, high risk GBS patients had higher rebleeding rates (hazard ratio [HR] 3.32, 95 % confidence interval [CI] 1.26 - 11.4). On multivariable analysis, patients with more co-morbidities (HR 1.06, 95 %CI 1.01 - 1.11) and cirrhosis (HR 2.23, 95 %CI 1.19 - 4.04) had higher 30-day readmission rates. CONCLUSIONS: High GBS scores were associated with higher rebleeding rates following discharge. Patients with high GBS scores (> 7) should be monitored following discharge as they have a high risk of rebleeding.

Laparoscopic-Assisted Percutaneous Endoscopic Gastrostomy.

There are a variety of techniques for gastrostomy tube placement. Endoscopic and radiologic approaches have almost entirely superseded surgical placement. However, an aging population and significant advancements in modern healthcare have resulted in patients with increasingly complex medical issues or postsurgical anatomy. The rising prevalence of obesity has also created technical challenges for proceduralists of many specialties. When patients with these comorbidities develop the need for long-term enteral nutrition and feeding tube placement, standard approaches such as percutaneous endoscopic gastrostomy (PEG) by endoscopists and percutaneous image-guided gastrostomy (PIG) by interventional radiologists may be technically difficult or impossible. For these challenging situations, laparoscopic-assisted PEG (LAPEG) is an alternative option. LAPEG combines the advantages of PEG with direct intraperitoneal visualization, helping ensure a safe tube placement tract free of intervening organs or structures. In this review, we highlight some of the important factors of first-line gastrostomy techniques, with an emphasis on the utility and procedural technique of LAPEG when they are not feasible.

Prior capsule endoscopy improves the diagnostic and therapeutic yield of single-balloon enteroscopy.

BACKGROUND AND AIMS: Although there is substantial literature addressing double-balloon enteroscopy, evidence is more limited with regard to the clinical utility of single-balloon enteroscopy (SBE) in evaluating and treating small-bowel diseases. We sought to determine the diagnostic and therapeutic yield of SBE in patients with suspected small-bowel disorders, as well as the impact of preceding capsule endoscopy (CE) on these outcomes. METHODS: We performed a retrospective analysis of a prospectively collected database at a tertiary-care academic medical center between 2011 and 2013 for all patients referred for SBE. RESULTS: A total of 150 patients underwent 170 SBE procedures during the study period. The most frequent indications for SBE included anemia, overt or occult gastrointestinal bleeding, and suspected mass. CE was performed prior to SBE in 113 of 150 patients (75%). The overall diagnostic yield for small-bowel disease by CE was 62%. Therapeutic interventions included hemostasis, polypectomy, and foreign body removal. Total diagnostic and therapeutic yield of SBE was 60 and 28%, respectively. The diagnostic yield of SBE with prior CE was 68 versus 44% for SBE without prior CE (P = 0.002). The therapeutic yield of SBE with prior CE was 35 versus 12% without prior CE (P = 0.001). One endoscopic complication was observed out of 170 procedures, and there were no deaths. CONCLUSIONS: SBE appears to be a safe and effective technique for the diagnosis and treatment of small-bowel disease; however, we recommend performing a CE prior to SBE to improve the diagnostic and therapeutic yield of the procedure.

Monitored anesthesia care without endotracheal intubation is safe and efficacious for single-balloon enteroscopy.

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

Curative Resection of T1a Inlet Patch Adenocarcinoma With Traction-Assisted Endoscopic Submucosal Dissection.

Esophageal inlet patch (EIP) adenocarcinoma is extremely rare. We present a case of a 58-year-old man who underwent a diagnostic esophagogastroduodenoscopy for dysphagia and found to have a 2 cm polypoid mass arising from an EIP. Biopsies and staging were consistent with T1aN0M0 EIP adenocarcinoma. While surgical resection was the main method of treatment of these lesions, very few case reports have shown that endoscopic resection can successfully remove these lesions. After multidisciplinary discussion, the patient underwent curative traction-assisted endoscopic submucosal dissection-which is the first known case report to highlight the success of this technique.

Endoscopic sleeve gastroplasty: the identification of the key procedural steps through a modified Delphi method.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an innovative, minimally invasive bariatric procedure with an excellent safety and efficacy profile in adults with obesity. The purpose of the procedure is to shorten and tubularize the stomach along its greater curvature. Nevertheless, there are some heterogeneities in the approach to ESG, which will be important to address as the procedure sees increasingly widespread clinical adoption. Here, an expert consensus on standardized ESG techniques is presented. METHODS: The modified Delphi method was used to establish the key procedural steps of an ESG. A panel of 8 experts was selected, of which 6 participated. The panel was selected based on their experience with performing the procedure and consisted of 1 bariatric surgeon and 5 interventional gastroenterologists. A neutral facilitator was designated and produced a skeletonized initial version of the key steps that was sent to each expert. Each survey began with the experts rating the given steps on a Likert scale of 1 to 5, with 1 being the most inaccurate and 5 being the most accurate. Furthermore, the final product was rated. The survey continued with open-ended questions designed to revise and polish the key steps. Areas of discrepancy were addressed using binary questions and a majority vote. The respondents were given 10 days to complete each survey. At the end of each round, the survey was redistributed with updated key steps and questions. This process was continued for a predesignated 3 rounds. RESULTS: Of the 8 experts who were queried, 6/8, 5/8, and 5/8 replied to each round. The given ratings for the accuracy of the steps in each round were 4.2, 4.6, and 4.4. The final rating was 4.8. Although expert opinion varied around smaller portions of the procedure, such as the placement of an overtube and the shape of each suture line, there was consensus on the need for full-thickness bites and appropriate swirling of the tissue with the helix device. Whether or not to include the fundus in the gastroplasty was an additional area of discrepancy. Of note, 4 of 5 experts agreed that the fundus should remain intact. The final protocol consisted of 21 steps curated from the summarized responses of the experts. CONCLUSION: Using the modified Delphi method, 21 key steps have been described for a safe and effective ESG. This rubric will be standardized across institutions and practitioners. Furthermore, these findings allow for the generation of educational assessment tools to facilitate training and increase the adoption of ESG by endoscopists.

Economic burden of enhanced practices of duodenoscopes reprocessing and surveillance: balancing risk and cost containment.

Background and study aims Recent outbreaks attributed to contaminated duodenoscopes have led to the development of enhanced surveillance and reprocessing techniques (enhanced-SRT) aimed at minimizing cross-contamination. Common enhanced-SRT include double high-level disinfection (HLD), ethylene oxide (EtO) gas sterilization, and culture-based monitoring of reprocessed scopes. Adoption of these methods adds to the operational costs and we aimed to assess its economic impact to an institution. Methods We compared the estimated costs of three enhanced-SRT versus single-HLD using data from two institutions. We examined the cost of capital measured as scope inventory and frequency of scope use per unit time, the constituent reprocessing costs required on a per-cycle basis, and labor & staffing needs. The economic impact attributable to enhanced-SRT was defined as the difference between the total cost of enhanced-SRT and single HLD. Results Compared to single HLD, adoption of double HLD increased the costs approximately by 47 % ($80 vs $118). Similarly, culture and quarantine and EtO sterilization increased costs by 160 % and 270 %, respectively ($80 vs $208 and $296). Enhanced-SRT introduced significant scope downtime due to prolonged techniques, necessitating a 3.4-fold increase in the number of scopes needed to maintain procedural volume. The additional annual budget required to implement enhanced-SRT approached $406,000 per year in high-volume centers. Conclusions While enhanced-SRT may reduce patient risk of exposure to contaminated duodenoscopes, it significantly increases the cost of performing ERCP. Future innovation should focus on approaches that can ensure patient safety while maintaining the ability to perform ERCP in a cost-effective manner.

Use of a novel single-use disposable duodenoscope for ERCP: selected clips from a real-world case series.

BACKGROUND AND AIMS: Single-use/disposable duodenoscopes represent one strategy to decrease the risk of patient infection related to ERCP. A preliminary case series was performed to demonstrate the feasibility and performance of a new single-use duodenoscope in a real-world clinical setting. METHODS: A single expert endoscopist performed ERCP for standard indications using a single-use duodenoscope. RESULTS: Videos of several key steps of ERCP obtained from 4 patients are shown to demonstrate that these steps can successfully be performed using the new single-use device. Clip 1 shows a patient with a large pancreatic duct stone in whom the image quality and maneuverability are demonstrated. Clip 2 shows a patient with choledocholithiasis and demonstrates bile duct cannulation, cholangiography, and sphincterotomy. Clip 3 shows a patient with acute cholecystitis and choledocholithiasis who underwent bile duct cannulation, sphincterotomy, and balloon sweeps. Clip 4 shows a patient with a history of liver transplant and refractory biliary anastomotic stricture who presented with abnormal liver tests and fever and underwent removal of a metal stent and placement of plastic stents. CONCLUSIONS: A single-use duodenoscope can successfully accomplish fundamental steps of ERCP. This device can potentially eliminate the risk of patient-to-patient infections linked to contaminated instruments. Larger studies are required to assess device performance.