Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Endoscopic full-thickness resection of polyps involving the appendiceal orifice: a multicenter international experience.

BACKGROUND: Endoscopic resection of lesions involving the appendiceal orifice remains a challenge. We aimed to report outcomes with the full-thickness resection device (FTRD) for the resection of appendiceal lesions and identify factors associated with the occurrence of appendicitis. METHODS: This was a retrospective study at 18 tertiary-care centers (USA 12, Canada 1, Europe 5) between November 2016 and August 2020. Consecutive patients who underwent resection of an appendiceal orifice lesion using the FTRD were included. The primary outcome was the rate of R0 resection in neoplastic lesions, defined as negative lateral and deep margins on post-resection histologic evaluation. Secondary outcomes included the rates of: technical success (en bloc resection), clinical success (technical success without need for further surgical intervention), post-resection appendicitis, and polyp recurrence. RESULTS: 66 patients (32 women; mean age 64) underwent resection of colonic lesions involving the appendiceal orifice (mean [standard deviation] size, 14.5 (6.2) mm), with 40 (61 %) being deep, extending into the appendiceal lumen. Technical success was achieved in 59/66 patients (89 %), of which, 56 were found to be neoplastic lesions on post-resection pathology. Clinical success was achieved in 53/66 (80 %). R0 resection was achieved in 52/56 (93 %). Of the 58 patients in whom EFTR was completed who had no prior history of appendectomy, appendicitis was reported in 10 (17 %), with six (60 %) requiring surgical appendectomy. Follow-up colonoscopy was completed in 41 patients, with evidence of recurrence in five (12 %). CONCLUSIONS: The FTRD is a promising non-surgical alternative for resecting appendiceal lesions, but appendicitis occurs in 1/6 cases.

Effectiveness and Safety of Lumen-Apposing Metal Stents in Endoscopic Interventions for Off-Label Indications.

BACKGROUND: Although released only for drainage of pseudocyst and walled-off necrosis (WON) with ≤ 30% solid debris, the utilization of lumen-apposing metal stent (LAMS) in "real-world" practice has deviated from approved indications. We evaluated the contemporary use of LAMS and associated clinical, procedural outcomes in the setting of a tertiary referral center in the USA. METHODS: Data from 303 consecutive patients who underwent LAMS placement were analyzed. Outcomes included technical and clinical success rates and adverse events. RESULTS: Of 303 patients, 190 (62.7%) received LAMS for off-label indications. The latter included gallbladder drainage (n = 56, 18.5%), gastroenterostomy (n = 52, 17.2%), treatment of gastrointestinal strictures (n = 37, 12.2%), biliary drainage (n = 20, 6.6%), temporary gastric access for endoscopy (n = 13, 4.3%), symptomatic WON with > 30% solid debris (n = 8, 2.6%), and miscellaneous (n = 4, 1.3%). Technical success rates in the on- and off-label arm were 98.2% and 95.8%, respectively (P = .331; 95% CI 0.08 to 1.96). Clinical success rates in the on- and off-label arm were 89.4% and 83.2%, respectively (P = .137; 95% CI 0.28 to 1.19). The rate of adverse events was 20.5% (n = 39) in the off-label arm and 16.8% (n = 19) in the on-label arm (P = .242; 95% CI 0.69 to 2.34). CONCLUSION: Off-label use of LAMS out-numbered on-label use in our practice. The safety profile between the groups was similar and with the exception of refractory stricture treatment, efficacy was comparable.

Effect of polyphenols on mixing properties and solvent retention of wheat flour doughs.

BACKGROUND: The effect of polyphenol addition on dough mixing properties and flour functionality was examined using flours from different wheat varieties. RESULTS: Both the mixograph and farinograph experiments showed that polyphenol addition affected dough stability and optimum mixing time. These effects were most apparent in hard wheat flour with the addition of catechin. Water absorption was dependent on wheat variety (P < 0.0001) but not on the addition of polyphenols (P = 0.54). Except for the 5 g kg-1 sodium carbonate solvent retention capacity (SRC), SRC values of the flours were dependent on wheat variety but not on polyphenol addition. However, 5 g kg-1 sodium carbonate SRC was significantly increased by the addition of caffeic acid and catechin. Since sodium carbonate SRC is associated with damaged starch levels, further investigations are needed to see how polyphenols influence either the absorption of a sodium carbonate solution or the starch itself. CONCLUSION: Polyphenol addition affected dough stability and optimum mixing time. Addition of catechin to hard wheat flour was most effective. Water absorption and SRC values except for 5 g kg-1 sodium carbonate solvent were affected by the wheat variety, but not by polyphenol addition. © 2021 Society of Chemical Industry.

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.).

Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND & AIMS: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days). RESULTS: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization. CONCLUSIONS: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.

Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.

BACKGROUND AND AIMS: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP. METHODS: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes. RESULTS: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01). CONCLUSIONS: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Long-Term Outcomes of Endoscopic Papillectomy for Ampullary Adenomas.

BACKGROUND AND AIMS: Endoscopic papillectomy is a safe and effective treatment for ampullary adenomas and has mostly replaced surgical local resection. Recent data have discussed the role of endoscopic removal of laterally spreading adenomas associated with ampullary adenomas. We evaluated our long-term results of endoscopic papillectomy for ampullary adenomas. METHODS: We retrospectively analyzed patients who underwent endoscopic papillectomy of biopsy-proven adenomas at our tertiary center between 1994 and 2017. Clinical success was defined as complete excision of an adenoma with no evidence of recurrence during follow-up, no evidence of cancer, and without the need for surgery. RESULTS: A total of 161 patients (73M/88F) with a mean age of 61 (range 19-93) were included. Mean adenoma size was 20 mm (range 5-70). In total, 114/161 patients continued endoscopic surveillance for a minimum of 6 months with a median follow-up of 30 months (range 6-283). Recurrent adenomas were diagnosed in 8 patients (7%) after a median of 36 months (range 12-138). Clinical success was 83%; 35 laterally spreading adenomas were treated, which were larger than adenomas confined to the papilla (mean size 38 mm vs 15 mm, P < 0.05) and required more piecemeal resections (77% vs 15%, P < 0.05). However, no difference was found in recurrence rates between the two groups (8% vs 4%, P = 0.26); 24/161 (15%) of patients had adverse events including bleeding (6%) and pancreatitis (7%). CONCLUSIONS: Endoscopic papillectomy is a safe and effective treatment for ampullary adenomas, including laterally spreading ones. Long-term surveillance demonstrates low recurrence rates at expert centers.

EUS-guided gallbladder drainage with a lumen-apposing metal stent versus endoscopic transpapillary gallbladder drainage for the treatment of acute cholecystitis (with videos).

BACKGROUND AND AIMS: There is an evolving role for EUS-guided transmural gallbladder (GB) drainage. Endoscopic transpapillary GB drainage is a well-established, nonoperative treatment for acute cholecystitis. We compared the outcomes of 78 cases of EUS-guided versus transpapillary GB drainage at a single, U.S.-based, high-volume endoscopy center. METHODS: This was a retrospective analysis performed from May 2013 to January 2018, identified from a database of nonoperative patients with acute cholecystitis. Both electrocautery-enhanced and nonelectrocautery-enhanced lumen-apposing metal stents were used. For transpapillary drainage, guidewire access was obtained and then a transpapillary 7F × 15-cm double-pigtail plastic stent was placed. RESULTS: In patients who had successful transpapillary or transmural drainage, demographics data were similar. Technical success was observed in 39 of 40 patients (97.5%) who underwent first attempt at EUS-guided drainage versus 32 of 38 patients (84.2%) for first-attempt transpapillary drainage (adjusted odds ratio, 9.83; 95% confidence interval, .93-103.86). Clinical success was significantly higher with EUS drainage in 38 of 40 patients (95.0%) versus transpapillary drainage in 29 of 38 patients (76.3%) (adjusted odds ratio, 7.14; 95% confidence interval, 1.32-38.52). Recurrent cholecystitis was lower in the EUS-guided drainage group (2.6% vs 18.8%, respectively; P = .023) on univariate analysis but only trended to significance in a multiple regression model. Duration of follow-up, reintervention rates, hospital length of stay, and overall adverse event rates were similar between groups. CONCLUSIONS: EUS-guided GB drainage results in a higher clinical success rate compared with transpapillary drainage and may be associated with a lower recurrence rate of cholecystitis. However, transpapillary drainage should be considered as the first-line treatment for patients who are surgical candidates but require temporizing measures or require an ERCP for alternative reasons.

The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital.

BACKGROUND: The utility of the American Society for Gastrointestinal Endoscopy (ASGE) grading scale assessing complexity of endoscopic retrograde cholangiopancreatography (ERCP) has not been evaluated in clinical practice. METHODS: Patients that underwent ERCP between January 2015 and December 2015 were included. Procedural difficulty was graded according to the grading system proposed by the ASGE workshop. Technical success rates and complications were recorded. RESULTS: A total of 1355 ERCPs were performed on 934 patients. Patients were equally divided with respect to gender and had a mean age of 58 years (range 29-86). 391 cases were grade 1, 2 (29%), 695 were grade 3 (51%), and 269 were grade 4 (20%). Altered anatomy was observed in 88% of grade 4 patients. Cannulation was achieved in 98% of cases graded 1-3 and in 88% of cases graded 4 (p < 0.05). Complications were recorded in 10% of all cases with post-ERCP pancreatitis (5.4%) and procedure-related bleeding (1.5%) being the more common ones. No statistically significant difference was noted between the groups with regard to complications. Three perforations were seen in grade 1-3 cases (0.3%) compared to 4 cases in grade 4 cases (1.5%), (p = 0.01). CONCLUSION: The grading system proposed by the ASGE workshop can aid in predicting cannulation success and perforation rates in ERCP. Based on this retrospective study, the most complex ERCP procedures can be achieved with encouraging rates of success. There is a need to validate our study with prospective ones performed in other high-volume centers.

Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.

BACKGROUND AND AIMS: Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key interventions in the optimization of a rigorous "culture and quarantine" program for duodenoscope reprocessing. METHODS: We reviewed a prospectively collected, quality assurance database of all duodenoscope cultures (n = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high-volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use. RESULTS: A total of 4307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a .697% high-level disinfection defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures. CONCLUSIONS: Withdrawal of duodenoscopes with a high rate of culture positivity and optimizing manual cleaning practices have contributed to an overall decline in the high-level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.

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.

The microbiology of infected pancreatic necrosis in the era of minimally invasive therapy.

We aimed to determine the microbiology of infected walled-off pancreatic necrosis (WON) in an era of minimally invasive treatment, since current knowledge is based on surgical specimens performed over two decades ago. We retrospectively analyzed a prospectively maintained database of patients who were treated for symptomatic WON using combined endoscopic and percutaneous drainage between 2008 and 2017. Aspirates from WON at initial treatment were evaluated. One hundred eighty-two patients were included with a mean age of 56 of whom 67% were male. Culture results were obtained at a median of 45 days from onset of acute pancreatitis of which 41% were infected. Candida spp. accounted for 27%; yet, multidrug-resistant organisms were found in only five patients. Approximately 64% were transferred to our institution for continuation of care. Of those, 55% were infected, most frequently with Candida spp., Enterococcus spp., and coagulase-negative Staphylococcus. Patients seen and admitted initially at our institution had milder forms of pancreatitis, fewer comorbidities, and 85% had symptomatic sterile WON. Empiric antibiotic use successfully predicted infection 70% of the time. Multivariate analysis demonstrated that elderly age, severity of pancreatitis, and prior use of antibiotics were indicators of infection. Necrotic pancreatic tissue remains sterile in the majority of cases treated with minimally invasive therapy, enabling judicious selection of antibiotics. Candida and Enterococcus spp. were common. Patients at highest risk for infection were previously treated with antibiotics and those transferred from outside institutions.

Duration of antibiotic treatment after endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis not affecting outcomes.

BACKGROUND AND AIM: Although society guidelines recommend a short course of antibiotics after drainage of walled-off necrosis (WON), the exact duration is unclear. METHODS: This is a retrospective review of patients with no prior antibiotic exposure who underwent dual-modality drainage (DMD) for sterile WON from 2008 to 2017. Patients were grouped into short duration (SD, ≤5 days) versus long duration (LD, >5 days). The main outcome was the frequency of recurrent infections. RESULTS: Sixty-one patients (25 in the SD group and 36 in the LD group) were included. Patients in the two groups had comparable age, comorbidities, and severity of disease (P = 0.89). Patients in the SD group were treated with antibiotics for a median of 3 days compared with 8.5 days in the LD group. There were no differences in recurrent febrile episodes within 30 days of procedure-44% of SD group versus 39% of LD (P = 0.69). There was also no difference in time to resolution of WON (64 days for both groups, P = 0.72) or duration of hospitalization post-DMD (SD 7.7 days versus LD 7.5 days, P = 0.42). Three cases of Clostridium difficile colitis were observed in the LD group. CONCLUSIONS: Longer course of antibiotics seems to have similar outcomes compared with shorter courses in patients with WON treated with DMD. Prolonged-course therapy may predispose to secondary infections like C. difficile colitis. A randomized controlled trial is needed to evaluate the role and duration of peri-procedural antibiotics after drainage of sterile WON.

New guidelines for use of endoscopic ultrasound for evaluation and risk stratification of pancreatic cystic lesions may be too conservative.

BACKGROUND: The role of EUS in managing asymptomatic pancreatic cystic lesions (PCLs) remains unresolved. We retrospectively evaluated EUS in risk stratification of PCLs when adhering to the most recent AGA guidelines. METHODS: Asymptomatic PCLs that were evaluated by EUS from January 2014 to December 2014 were retrospectively reviewed including associated cytology, fluid analysis, and relevant surgical pathology. Cross-sectional imaging reports were reviewed blindly by an expert radiologist using AGA risk stratification terminology. Accepted imaging high-risk features (HRF) included cyst diameter > 3 cm, dilated upstream pancreatic ducts, and a solid component in the cyst. RESULTS: We reviewed 125 patients who underwent EUS. Expert review of cross-sectional imaging resulted in a different interpretation 25% of the time including 1 malignant cyst. Ninety-three patients (75%) had no HRFs on cross-sectional imaging; 28 patients (22%) were diagnosed with 1 HRF and 4 patients (3%) had 2 HRFs. Adhering to AGA guidelines using 2 HRF as threshold for use of EUS, the diagnosis of malignant and high-risk premalignant lesions (including pancreatic adenocarcinoma, mucinous cystadenoma, neuroendocrine tumors, and IPMN with dysplasia) had a 40% sensitivity and 100% specificity. Had EUS been utilized based on a threshold of 1 HRF on imaging, malignant and high-risk premalignant lesions would have been identified with 80% sensitivity and 95% specificity. By adding EUS to radiographic imaging, the specificity for detecting carcinomas (p = 0.0009) and detection of all premalignant lesions (p = 0.003) statistically improved. Furthermore, EUS allowed 14 patients (11%) to avoid further surveillance by lowering their risk stratification. CONCLUSION: EUS remains an essential risk stratification modality for incidental PCLs. Current guideline suggestions of its utility may be too stringent. Our study justifies expert radiology review when managing PCLs. Further studies are required to identify the optimal approach to PCL management.

A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli.

BACKGROUND: Because of their complex design, duodenoscopes have been long recognized to be difficult to fully disinfect and may play a role in transmission of bacteria between patients. Recent reports of duodenoscope-associated carbapenem-resistant enterobacteriaceae transmission have confirmed these suspicions. An outbreak of a multidrug resistant strain of Escherichia coli was recently reported at our institution. Herein we report the results of our investigation and the process improvements that we deployed in an effort to contain the outbreak. METHODS: A full investigation into the environment, endoscopists, infection control practices, high-level disinfection process as well as endoscopes was undertaken in conjunction with the local county health authority and the Centers for Disease Control and Prevention. Duodenoscopes were cultured and quarantined for 48 hours until negative cultures were obtained. Ergonomic changes were made to the endoscope reprocessing area, duodenoscopes were returned for routine maintenance, and surveillance cultures were obtained from all patients undergoing ERCP. RESULTS: Between November 2012 and August 2013, 32 patients were found to harbor 1 of 2 clonal strains of multidrug-resistant E coli, all of whom had undergone ERCP or duodenoscopy. A total of 1149 ERCPs were performed during this time period. Seven patients died within 31 days of the organism being identified in culture, 16 patients died overall by March 2015. The exact contribution of E coli to death is unclear because most patients had underlying late-stage malignancy or other severe medical comorbidities. No breach in high-level disinfection protocol or infection control practices was identified. The clonal strain of E coli was identified in culture on 4 of 8 duodenoscopes, 3 of which required critical repairs despite lack of obvious malfunction. The defect rate in high-level disinfection of duodenoscopes was 2% over a 1-year period. The implemented quality improvements, subsequent to which 1625 ERCPs have been performed, were successful in halting the outbreak. CONCLUSIONS: The existing manufacturer-recommended high-level disinfection protocols for duodenoscopes are inadequate. Although the ultimate solution may be a design change to the instrument, the timeline for such a change appears long and potentially difficult to exact. In the interim, a reliable method to ensure that bacterial pathogens are not present on the duodenoscope after high-level disinfection is needed.

Endoscopic treatment of nonstricture-related benign biliary diseases using covered self-expandable metal stents.

BACKGROUND AND STUDY AIMS: Nonstricture benign biliary diseases (BBDs) such as leaks, perforations, and bleeding, have been traditionally managed by placement of one or more plastic stents. Emerging data support the use of covered, self-expandable, metal stents (CSEMSs). The aim of this study was to assess the outcomes of endoscopic temporary placement of CSEMS in patients with nonstricture BBD. PATIENTS AND METHODS: This was a retrospective study of CSEMS placement for BBD between May 2005 and August 2013 at two tertiary care centers. The main outcome measures were resolution of perforation, bleeding, leak, and adverse events related to CSEMS treatment. RESULTS: A total of 87 patients were included (median age 62 years [range 18 - 86]). Indications for stent placement were bile leaks (n = 35, 40 %), bleeding (n = 27, 31 %), perforation (n = 18, 21 %), and other conditions (n = 7, 8 %). Fully and partially covered 8 - 10-mm diameter CSEMS were placed and subsequently removed in all 87 patients (100 %). Resolution of the underlying problem was achieved for 33 bile leaks (94 %), 25 bleedings (93 %), 18 perforations (100 %), and for 3 cases with other indications (43 %). The median duration of stenting was 9 weeks in patients with biliary leaks, 3 weeks for bleeding, and 9.5 weeks for perforations. Median follow-up was 82 weeks after stent removal. Seven adverse events occurred, including cholangitis in six patients (7 %), and tissue hyperplasia leading to difficulty in the removal of a partially covered SEMS in one patient. CONCLUSIONS: Nonstricture BBD can be effectively and safely treated with the short term placement of CSEMS. .