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Browsing by Author "Coté, Gregory A."

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    Constant-Severe Pain in Chronic Pancreatitis is Associated with Genetic Loci for Major Depression in the NAPS2 Cohort
    (Springer, 2020) Dunbar, Ellyn; Greer, Phil J.; Melhem, Nadine; Alkaade, Samer; Amann, Stephen T.; Brand, Randall; Coté, Gregory A.; Forsmark, Christopher E.; Gardner, Timothy B.; Gelrud, Andres; Guda, Nalini M.; LaRusch, Jessica; Lewis, Michele D.; Machicado, Jorge D.; Muniraj, Thiruvengadam; Papachristou, Georgios I.; Romagnuolo, Joseph; Sandhu, Bimaljit S.; Sherman, Stuart; Wilcox, Charles M.; Singh, Vikesh K.; Yadav, Dhiraj; Whitcomb, David C.; NAPS2 study group; Medicine, School of Medicine
    Background: Pain is the most debilitating symptom of recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP) and often requires chronic opioids or total pancreatectomy with islet autotransplantation to manage. Pain is a complex experience that can be exacerbated by depression and vice versa. Our aim was to test the hypothesis that depression-associated genes are associated with a constant-severe pain experience in RAP/CP patients. Study: A retrospective study was done using North American Pancreatitis Study II (NAPS2) genotyped RAP and CP patients with completed case report forms (n = 1,357). Subjects were divided based on pattern of pain and pain severity as constant-severe pain (n = 787) versus not constant-severe pain (n = 570) to conduct a nested genome-wide association study. The association between reported antidepressant medication use and depression gene loci was tested. Results: Constant-severe pain was reported in 58% (n = 787) of pancreatitis patients. No differences in sex or alcohol consumption were found based on pain severity. Antidepressant use was reported in 28% (n = 223), and they had lower SF-12 mental quality of life (MCS, p < 2.2 × 10- 16). Fifteen loci associated with constant-severe pain (p < 0.00001) were found to be in or near depression-associated genes including ROBO2, CTNND2, SGCZ, CNTN5 and BAIAP2. Three of these genes respond to antidepressant use (SGCZ, ROBO2, and CTNND2). Conclusion: Depression is a major co-factor in the pain experience. This genetic predisposition to depression may have utility in counseling patients and in instituting early antidepressant therapy for pain management of pancreatitis patients. Prospective randomized trials are warranted.
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    Development and Validation of a Prediction Model for Admission After Endoscopic Retrograde Cholangiopancreatography
    (Elsevier, 2015-12) Coté, Gregory A.; Lynch, Sheryl; Easler, Jeffrey J.; Keen, Alyson; Vassell, Patricia A.; Sherman, Stuart; Hui, Siu; Xu, Huiping; Department of Medicine, IU School of Medicine
    BACKGROUND & AIMS: In outpatients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with anesthesia, rates of and risk factors for admission are unclear. We aimed to develop a model that would allow physicians to predict hospitalization of patients during postanesthesia recovery. METHODS: We conducted a retrospective study of data from ERCPs performed on outpatients from May 2012 through October 2013 at the Indiana University School of Medicine. Medical records were abstracted for preanesthesia, intra-anesthesia, and early (within the first hour) postanesthesia characteristics potentially associated with admission. Significant factors associated with admission were incorporated into a logistic regression model to identify subgroups with low, moderate, or high probabilities for admission. The population was divided into training (first 12 months) and validation (last 6 months) sets to develop and test the model. RESULTS: We identified 3424 ERCPs during the study period; 10.7% of patients were admitted to the hospital, and 3.7% developed post-ERCP pancreatitis. Postanesthesia recovery times were significantly longer for patients requiring admission (362.6 ± 213.0 minutes vs 218.4 ± 71.8 minutes for patients not admitted; P < .0001). A higher proportion of admitted patients had high-risk indications. Admitted patients also had more severe comorbidities, higher baseline levels of pain, longer procedure times, performance of sphincter of Oddi manometry, higher pain during the first hour after anesthesia, and greater use of opiates or anxiolytics. A multivariate regression model identified patients who were admitted with a high level of accuracy in the training set (area under the curve, 0.83) and fair accuracy in the validation set (area under the curve, 0.78). On the basis of this model, nearly 50% of patients could be classified as low risk for admission. CONCLUSION: By using factors that can be assessed through the first hour after ERCP, we developed a model that accurately predicts which patients are likely to be admitted to the hospital. Rates of admission after outpatient ERCP are low, so a policy of prolonged observation might be unnecessary.
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    Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution A Randomized Clinical Trial
    (JAMA, 2016-03) Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart; Department of Biostatistics, Richard M. Fairbanks School of Public Health
    Importance Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. Objective To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. Design, Setting, and Participants Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. Interventions Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. Main Outcomes and Measures Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. Results There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). Conclusions and Relevance Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these.
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    Endoscopic Palliation of Pancreatic Cancer
    (Wolters Kluwer, 2012) Coté, Gregory A.; Sherman, Stuart; Medicine, School of Medicine
    Endoscopy has an increasingly important role in the palliation of patients with pancreatic ductal adenocarcinoma. Endoscopic biliary drainage is still requested in the majority of patients who present with obstructive jaundice, and the increased use of self-expandable metallic stents has reduced the incidence of premature stent occlusion. First-line use of metallic stents is expected to be utilized more frequently as neoadjuvant protocols are improved. The efficacy of endoscopy for palliating gastroduodenal obstruction has advanced with the development of through-the-scope, self-expandable gastroduodenal stents. There have been advances in pain management, with endoscopic ultrasound-guided celiac plexus neurolysis reducing opiate requirements and pain for patients with unresectable malignancy. Future applications of endoscopy in pancreatic cancer may include fine-needle injection of chemotherapeutic and other agents into the lesion itself. This review will summarize the evidence of endoscopy in the management of patients with pancreatic cancer.
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    Endoscopic papillectomy: risk factors for incomplete resection and recurrence during long-term follow-up
    (Elsevier, 2014-02) Ridtitid, Wiriyaporn; Tan, Damien; Schmidt, Suzette E.; Fogel, Evan L.; McHenry, Lee; Watkins, James L.; Lehman, Glen A.; Sherman, Stuart; Coté, Gregory A.; Department of Medicine, IU School of Medicine
    Background Endoscopic papillectomy is increasingly used as an alternative to surgery for ampullary adenomas and other noninvasive ampullary lesions. Objective To measure short-term safety and efficacy of endoscopic papillectomy, define patient and lesion characteristics associated with incomplete endoscopic resection, and measure adenoma recurrence rates during long-term follow-up. Design Retrospective cohort study. Setting Tertiary-care academic medical center. Patients All patients who underwent endoscopic papillectomy for ampullary lesions between July 1995 and June 2012. Intervention Endoscopic papillectomy. Main Outcome Measurements Patient and lesion characteristics associated with incomplete endoscopic resection and ampullary adenoma-free survival analysis. Results We identified 182 patients who underwent endoscopic papillectomy, 134 (73.6%) having complete resection. Short-term adverse events occurred in 34 (18.7%). Risk factors for incomplete resection were jaundice at presentation (odds ratio [OR] 0.21, 95% confidence interval [CI] 0.07–0.69; P = .009), occult adenocarcinoma (OR 0.06, 95% CI, 0.01–0.36; P = .002), and intraductal involvement (OR 0.29, 95% CI, 0.11–0.75; P = .011). The en bloc resection technique was strongly associated with a higher rate of complete resection (OR 4.05, 95% CI, 1.71–9.59; P = .001). Among patients with ampullary adenoma who had complete resection (n = 107), 16 patients (15%) developed recurrence up to 65 months after resection. Limitations Retrospective analysis. Conclusion Jaundice at presentation, occult adenocarcinoma in the resected specimen, and intraductal involvement are associated with a lower rate of complete resection, whereas en bloc papillectomy increases the odds of complete endoscopic resection. Despite complete resection, recurrence was observed up to 5 years after papillectomy, confirming the need for long-term surveillance.
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    Endoscopic Treatment of Acute Biliary Diseases: Have We Optimized the Value of Inpatient Endoscopic Retrograde Cholangiopancreatography?
    (Elsevier B.V., 2014-07) Coté, Gregory A.; Department of Medicine, IU School of Medicine
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    Evaluating Adults With Idiopathic Pancreatitis for Genetic Predisposition: Higher Prevalence of Abnormal Results With Use of Complete Gene Sequencing
    (Wolters Kluwer, 2015-01) Ballard, Darren D.; Flueckiger, Joyce R.; Fogel, Evan L.; McHenry, Lee; Lehman, Glen A.; Watkins, James L.; Sherman, Stuart; Coté, Gregory A.; Department of Medicine, IU School of Medicine
    OBJECTIVES: In adults with unexplained pancreatitis, the yield of complete gene versus select exosome sequencing on mutation detection and distinguishing clinical characteristics associated with mutations requires clarification. We sought to (1) compare frequency of mutations identified using different techniques and (2) compare clinical characteristics between adults with and without mutations. METHODS: This is a cohort study of adults with unexplained pancreatitis who underwent genetic testing between January 2008 and December 2012. We compare probabilities of having a positive mutation with complete gene sequencing versus alternatives and describe differences in characteristics among patients with and without mutations. RESULTS: Of the 370 patients, 67 (18%) had a genetic mutation; 24 (6%) were of high risk. Mutations were significantly more prevalent with use of complete sequencing (42%) versus other approaches (8%, P < 0.0001). Most (44/67, 66%) with a mutation had no family history. Those with high-risk mutations were more likely to have a family history of chronic pancreatitis (21% vs 4%, P = 0.002). Patients with pancreas divisum were more likely to have mutations (27% vs 14%, P = 0.0007). CONCLUSION: Among individuals with adult-onset pancreatic disease, the probability of finding any mutation, including high risk, is significantly higher using complete gene sequencing. The impact on patients and providers requires further investigation.
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    Interventions for Pancreatitis-New Approaches, Knowledge Gaps, and Research Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop
    (Wolters Kluwer, 2024) Evans Phillips, Anna; Hughes, Steven J.; Andersen, Dana K.; Bell, Adam; Brand, Randall; Coté, Gregory A.; Cowdin, Adriana; Diazgranados, Nancy; Dudeja, Vikas; Duggan, Sinead N.; Fogel, Evan; Forsmark, Chris E.; Freeman, A. Jay; Gittes, George; Hart, Phil A.; Jeon, Christie; Nealon, William; Neoptolemos, John; Palermo, Tonya M.; Pandol, Stephen; Roberts, Kristen M.; Rosenthal, Martin; Singh, Vikesh K.; Yadav, Dhiraj; Whitcomb, David C.; Zyromski, Nicholas; Medicine, School of Medicine
    There exists no cure for acute, recurrent acute or chronic pancreatitis and treatments to date have been focused on managing symptoms. A recent workshop held by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) focused on interventions that might disrupt or perhaps even reverse the natural course of this heterogenous disease, aiming to identify knowledge gaps and research opportunities that might inform future funding initiatives for NIDDK. The breadth and variety of identified active or planned clinical trials traverses the spectrum of the disease and was conceptually grouped for the workshop into behavioral, nutritional, pharmacologic and biologic, and mechanical interventions. Cognitive and other behavioral therapies are proven interventions for pain and addiction, but barriers exist to their use. Whilst a disease specific instrument quantifying pain is now validated, an equivalent is lacking for nutrition - and both face challenges in ease and frequency of administration. Multiple pharmacologic agents hold promise. Ongoing development of Patient Reported Outcome (PRO) measurements can satisfy Investigative New Drug (IND) regulatory assessments. Despite multiple randomized clinical trials demonstrating benefit, great uncertainty remains regarding patient selection, timing of intervention, and type of mechanical intervention (endoscopic versus surgery). Challenges and opportunities to establish beneficial interventions for patients were identified.
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    Lower provider volume is associated with higher failure rates for endoscopic retrograde cholangiopancreatography
    (Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2013-12) Coté, Gregory A.; Imler, Timothy D.; Xu, Huiping; Teal, Evgenia; French, Dustin D.; Imperiale, Thomas F.; Rosenman, Marc B.; Wilson, Jeffrey S.; Hui, Siu L.; Sherman, Stuart; Department of Medicine, IU School of Medicine
    BACKGROUND: Among physicians who perform endoscopic retrograde cholangiopancreatography (ERCP), the relationship between procedure volume and outcome is unknown. OBJECTIVE: Quantify the ERCP volume-outcome relationship by measuring provider-specific failure rates, hospitalization rates, and other quality measures. RESEARCH DESIGN: Retrospective cohort. SUBJECTS: A total of 16,968 ERCPs performed by 130 physicians between 2001 and 2011, identified in the Indiana Network for Patient Care. MEASURES: Physicians were classified by their average annual Indiana Network for Patient Care volume and stratified into low (<25/y) and high (≥25/y). Outcomes included failed procedures, defined as repeat ERCP, percutaneous transhepatic cholangiography or surgical exploration of the bile duct≤7 days after the index procedure, hospitalization rates, and 30-day mortality. RESULTS: Among 15,514 index ERCPs, there were 1163 (7.5%) failures; the failure rate was higher among low (9.5%) compared with high volume (5.7%) providers (P<0.001). A second ERCP within 7 days (a subgroup of failure rate) occurred more frequently when the original ERCP was performed by a low-volume (4.1%) versus a high-volume physician (2.3%, P=0.013). Patients were more frequently hospitalized within 24 hours when the ERCP was performed by a low-volume (28.3%) versus high-volume physician (14.8%, P=0.002). Mortality within 30 days was similar (low=1.9%, high=1.9%). Among low-volume physicians and after adjusting, the odds of having a failed procedure decreased 3.3% (95% confidence interval, 1.6%-5.0%, P<0.001) with each additional ERCP performed per year. CONCLUSIONS: Lower provider volume is associated with higher failure rate for ERCP, and greater need for postprocedure hospitalization.
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    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 Medicine
    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 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.
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