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Item Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective, randomized study(Elsevier, 2020) Gromski, Mark A.; Sieber, Marnie S.; Sherman, Stuart; Rex, Douglas K.; Medicine, School of MedicineBackground and Aims The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiological culturing of duodenoscopes and reprocessing with repeat high-level disinfection or liquid chemical sterilization have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration (FDA). This study aims to compare the efficacy of reprocessing duodenoscopes with double high-level disinfection (DHLD) versus liquid chemical sterilization (LCS). Methods We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol. Results During the study time period, there were 878 postreprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all of the cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) to duodenoscopes undergoing LCS (9 positive cultures, 2.1%, p=0.8). Both groups had 2 cultures that grew high-concern organisms (0.5% vs. 0.5%, p=1.0). No multi-drug resistant organisms (MDRO), including carbapenem-resistant enterobacteriaceae (CRE), were detected. Conclusions DHLD and LCS both resulted in a low rate of positive cultures, both for all organisms and for high-concern organisms, but neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.Item End of the Road for Epinephrine Spraying of the Papilla to Prevent Post–Endoscopic Retrograde Cholangiopancreatography Pancreatitis?(Elsevier, 2019) Gromski, Mark A.; Fogel, Evan L.; Medicine, School of MedicineEndoscopic retrograde cholangiopancreatography (ERCP) remains the endoscopic intervention that is routinely performed by gastroenterologists that carries the highest risk of serious adverse events, the most frequent of which is post-ERCP pancreatitis (PEP). Substantial efforts have been undertaken to further the science of patient selection and prophylactic measures to reduce the risk of PEP. Yet, the rate of PEP pancreatitis remains 3%–15%, dependent on patient, procedure, and provider risk factors.Item Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass(Elsevier, 2017) Abbas, Ali M.; Strong, Andrew T.; Diehl, David L.; Brauer, Brian C.; Lee, Iris H.; Burbridge, Rebecca; Zivny, Jaroslav; Higa, Jennifer T.; Falcão, Marcelo; El Hajj, Ihab I.; Tarnasky, Paul; Enestvedt, Brintha K.; Ende, Alexander R.; Thaker, Adarsh M.; Pawa, Rishi; Jamidar, Priya; Sampath, Kartik; de Moura, Eduardo Guimarães Hourneaux; Kwon, Richard S.; Suarez, Alejandro L.; Aburajab, Murad; Wang, Andrew Y.; Shakhatreh, Mohammad H.; Kaul, Vivek; Kang, Lorna; Kowalski, Thomas E.; Pannala, Rahul; Tokar, Jeffrey; Aadam, A. Aziz; Tzimas, Demetrios; Wagh, Mihir S.; Draganov, Peter V.; Ponsky, Jeffrey; Greenwald, Bruce D.; Uradomo, Lance T.; McGhan, Alyson A.; Hakimian, Shahrad; Ross, Andrew; Sherman, Stuart; Bick, Benjamin L.; Forsmark, Christopher E.; Yang, Dennis; Gupte, Anand; Chauhan, Shailendra; Hughes, Steven J.; Saks, Karen; Bakis, Gennadiy; Templeton, Adam W.; Saunders, Michael; Sedarat, Alireza; Evans, John A.; Muniraj, Thiruvengadam; Gardner, Timothy B.; Ramos, Almino C.; Santo, Marco Aurelio; Nett, Andrew; Coté, Gregory A.; Elmunzer, Joseph; Dua, Kulwinder S.; Nosler, Michael J.; Strand, Daniel S.; Yeaton, Paul; Kothari, Shivangi; Ullah, Asad; Taunk, Pushpak; Brady, Patrick; Pinkas, Haim; Faulx, Ashley L.; Shahid, Haroon; Holmes, Jordan; Pannu, Davinderbir; Komanduri, Srinadh; Bucobo, Juan Carlos; Dhaliwal, Harry; Rostom, Alaa; Acker, Brent W.; Medicine, School of MedicineBackground 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 due to surgically altered gastroduodenal anatomy. Laparoscopic-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 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 of 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 (IQR 109-210) with median ERCP time 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. Conclusion 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. ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher due to the added laparoscopy-related events.Item Provider-specific quality measurement for ERCP using natural language processing(Elsevier, 2017) Imler, Timothy D.; Sherman, Stuart; Imperiale, Thomas F.; Xu, Huiping; Ouyang, Fangqian; Beesley, Christopher; Hilton, Charity; Coté, Gregory A.; Department of Medicine, IU School of MedicineBackground and Aims Natural language processing (NLP) is an information retrieval technique that has been shown to accurately identify quality measures for colonoscopy. There are no systematic methods by which to track adherence to quality measures for ERCP, the highest risk endoscopic procedure widely used in practice. Our aim was to demonstrate the feasibility of using NLP to measure adherence to ERCP quality indicators across individual providers. Methods ERCPs performed by 6 providers at a single institution from 2006 to 2014 were identified. Quality measures were defined using society guidelines and from expert opinion, and then extracted using a combination of NLP and data mining (eg, ICD9-CM codes). Validation for each quality measure was performed by manual record review. Quality measures were grouped into preprocedure (5), intraprocedure (6), and postprocedure (2). NLP was evaluated using measures of precision and accuracy. Results A total of 23,674 ERCPs were analyzed (average patient age, 52.9 ± 17.8 years, 14,113 were women [59.6%]). Among 13 quality measures, precision of NLP ranged from 84% to 100% with intraprocedure measures having lower precision (84% for precut sphincterotomy). Accuracy of NLP ranged from 90% to 100% with intraprocedure measures having lower accuracy (90% for pancreatic stent placement). Conclusions NLP in conjunction with data mining facilitates individualized tracking of ERCP providers for quality metrics without the need for manual medical record review. Incorporation of these tools across multiple centers may permit tracking of ERCP quality measures through national registries.Item Rectal Indomethacin Dose Escalation (RIDE) for Prevention of Post-ERCP Pancreatitis in High-Risk Patients: a Randomized Trial(Elsevier, 2020-02) Fogel, Evan L.; Lehman, Glen A.; Tarnasky, Paul; Cote, Gregory A.; Schmidt, Suzette E.; Waljee, Akbar K.; Higgins, Peter D. R.; Watkins, James L.; Sherman, Stuart; Kwon, Richard S. Y.; Elta, Grace H.; Easler, Jeffrey J.; Pleskow, Douglas K.; Scheiman, James M.; El Hajj, Ihab I.; Guda, Nalini M.; Gromski, Mark A.; McHenry, Lee, Jr.; Arol, Seena; Korsnes, Sheryl; Suarez, Alejandro L.; Spitzer, Rebecca; Miller, Marilyn; Hofbauer, Maria; Elmunzer, Badih Joseph; Medicine, School of MedicineBackground Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients. Methods In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete. Findings Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients—76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87–1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients—six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up. Interpretation Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.Item SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications(Wolters Kluwer, 2019-09-01) Coté, Gregory A.; Durkalski-Mauldin, Valerie L.; Serrano, Jose; Klintworth, Erin; Williams, April W.; Cruz-Monserrate, Zobeida; Arain, Mustafa; Buxbaum, James L.; Conwell, Darwin L.; Fogel, Evan L.; Freeman, Martin L.; Gardner, Timothy B.; van Geenen, Erwin; Groce, J. Royce; Jonnalagadda, Sreenivasa S.; Keswani, Rajesh N.; Menon, Shyam; Moffatt, Dana C.; Papachristou, Georgios I.; Ross, Andrew; Tarnasky, Paul R.; Wang, Andrew Y.; Wilcox, C. Mel; Hamilton, Frank; Yadav, Dhiraj; Consortium for the SHARP; Medicine, School of MedicineObjectives: In patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis. Methods: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES vs. endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having two or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and maximum of 48 months. Results: The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. Conclusions: The SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.