Browsing by Author "Hughes, Steven J."

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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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    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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    PROspective Evaluation of Chronic Pancreatitis for EpidEmiologic and Translational StuDies: Rationale and Study Design for PROCEED From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
    (Wolters Kluwer, 2018-11) Yadav, Dhiraj; Park, Walter G.; Fogel, Evan L.; Li, Liang; Chari, Suresh T.; Feng, Ziding; Fisher, William E.; Forsmark, Christopher E.; Jeon, Christie Y.; Habtezion, Aida; Hart, Phil A.; Hughes, Steven J.; Othman, Mohamed O.; Rinaudo, Jo Ann; Pandol, Stephen J.; Tirkes, Temel; Serrano, Jose; Srivastava, Sudhir; Van Den Eeden, Stephen K.; Whitcomb, David C.; Topazian, Mark; Conwell, Darwin L.; Medicine, School of Medicine
    Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED) is the first prospective, observational cohort study of chronic pancreatitis (CP) in the United States. The primary goals of PROCEED are to define disease progression, test the predictive capability of candidate biomarkers, and develop a platform to conduct translational and mechanistic studies in CP. Using objective and consensus-driven criteria, PROCEED will enroll adults at different stages of CP-controls, suspected CP, and definite CP. In addition to collecting detailed information using structured case report forms and protocol-mandated evaluations at baseline and during follow-up, PROCEED will establish a linked biorepository of blood, urine, saliva, stool, pancreatic fluid, and pancreatic tissue. Enrollment for PROCEED began in June 2017. As of July 1, 2018, nine clinical centers of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer are enrolling, and 350 subjects have completed baseline evaluation. In conclusion, PROCEED will provide the most accurate and reliable estimates to date on progression of CP. The established cohort and biorepository will facilitate numerous analyses, leading to new strategies for diagnosis, methods to monitor disease progression, and treatment of CP.
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    A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
    (Wolters Kluwer, 2018-11) Maitra, Anirban; Sharma, Ayush; Brand, Randall E.; Van Den Eeden, Stephen K.; Fisher, William E.; Hart, Phil A.; Hughes, Steven J.; Mather, Kieren J.; Pandol, Stephen J.; Park, Walter G.; Feng, Ziding; Serrano, Jose; Rinaudo, Jo Ann; Srivastava, Sudhir; Chari, Suresh T.; Medicine, School of Medicine
    The National Cancer Institute and the National Institute for Diabetes and Digestive and Kidney Diseases initiated the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) in 2015 (the CPDPC's origin, structure, governance, and research objectives are described in another article in this journal). One of the key objectives of CPDPC is to assemble a cohort of 10,000 subjects 50 years or older with new-onset diabetes, called the NOD cohort. Using a define, enrich, and find early detection approach, the aims of the NOD study are to (a) estimate the 3-year probability of pancreatic ductal adenocarcinoma (PDAC) in NOD (define), (b) establish a biobank of clinically annotated biospecimens from presymptomatic PDAC and control new-onset type 2 diabetes mellitus subjects, (c) conduct phase 3 validation studies of promising biomarkers for identification of incident PDAC in NOD patients (enrich), and (d) provide a platform for development of a future interventional screening protocol for early detection of PDAC in patients with NOD that incorporates imaging studies and/or clinical algorithms (find). It is expected that 85 to 100 incidences of PDAC will be diagnosed during the study period in this cohort of 10,000 patients.