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1. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}

Author

Wilcox, C. Mel, Bang, Ji Young, Buxbaum, James, Gardner, Timothy B., Hawes, Robert, Kedia, Prashant, Mardini, Samuel H., Muniraj, Thiruvengadam, Navaneethan, Udayakumar, Oza, Veeral M., Tarnasky, Paul, Thakkar, Shyam, Waxman, Irving, and Varadarajulu, Shyam

Published
2024
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2. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}

Author

C. Mel Wilcox, Ji Young Bang, James Buxbaum, Timothy B. Gardner, Robert Hawes, Prashant Kedia, Samuel H. Mardini, Thiruvengadam Muniraj, Udayakumar Navaneethan, Veeral M. Oza, Paul Tarnasky, Shyam Thakkar, Irving Waxman, Shyam Varadarajulu, and on behalf of the US Pancreatic Disease Study Group

Subjects
Chronic pancreatitis, Celiac plexus block, Abdominal pain, Endoscopic ultrasonography, Medicine (General), R5-920
Abstract

Abstract Background Celiac plexus block has been commonly utilized for the treatment of chronic pancreatitis-associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis. Methods This is a two-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at 1 month post-intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) pain scores, and quality of life using a pancreas-specific validated measure (PANQOLI). Discussion In this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting. Trial registration {2} ClinicalTrials.gov NCT 06178315. Registered on December 21, 2023

Published
2024
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4. Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use

Author

Maranki, Jennifer L., Schwaitzberg, Steven D., Sharaiha, Reem Z., Kushnir, Vladimir M., Badurdeen, Dilhana S., Kumbhari, Vivek, Gómez, Victoria, Kumta, Nikhil A., Waye, Jerome D., Nieto, Jose, Ujiki, Michael B., Benias, Petros C., Miller, Larry S., Kedia, Prashant, Tarnasky, Paul, Mathew, Abraham, Levenick, John M., Inamdar, Sumant, Tharian, Benjamin, Nersesova, Yanina, Fredell, Lydia, Serra, Sonya, and Kochman, Michael L.

Published
2022
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5. Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial

Author

Buxbaum, James, Dai, Sun-Chuan, Elmunzer, Joe, Fogel, Evan, Freeman, Martin, Gaddam, Srinivas, Gardner, Timothy B., Groce, Royce, Inamdar, Sumant, Jamidar, Priya, Jonnalagadda, Srinivas, Keswani, Rajesh, Moffat, Dana, Pleskow, Doug, Ross, Andrew, Tarnasky, Paul, van Geenan, Erwin, Wang, Andrew, Willingham, Field, Cote, Gregory A., Durkalski-Mauldin, Valerie, Williams, April, Nitchie, Haley, Serrano, Jose, and Yadav, Dhiraj

Published
2023
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6. Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial

Author

Sherman, Stuart, Kozarek, Richard A., Costamagna, Guido, Reddy, D. Nageshwar, Tarnasky, Paul, Shah, Raj J., Slivka, Adam, Fogel, Evan, Watkins, James, Delhaye, Myriam, Irani, Shayan S., Tringali, Andrea, Lakhtakia, Sundeep, Kedia, Prashant, Edmundowicz, Steven, Peetermans, Joyce A., Rousseau, Matthew J., and Devière, Jacques

Published
2023
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7. Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry

Author

Smith, MS, Cash, B, Konda, V, Trindade, AJ, Gordon, S, DeMeester, S, Joshi, V, Diehl, D, Ganguly, E, Mashimo, H, Singh, S, Jobe, B, McKinley, M, Wallace, M, Komatsu, Y, Thakkar, S, Schnoll-Sussman, F, Sharaiha, R, Kahaleh, M, Tarnasky, P, Wolfsen, H, Hawes, R, Lipham, J, Khara, H, Pleskow, D, Navaneethan, U, Kedia, P, Hasan, M, Sethi, A, Samarasena, J, Siddiqui, UD, Gress, F, Rodriguez, R, Lee, C, Gonda, T, Waxman, I, Hyder, S, Poneros, J, Sharzehi, K, Di Palma, JA, Sejpal, DV, Oh, D, Hagen, J, Rothstein, R, Sawhney, M, Berzin, T, Malik, Z, and Chang, K

Subjects
Digestive Diseases, Biomedical Imaging, Clinical Research, Cancer, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Adult, Aged, Aged, 80 and over, Barrett Esophagus, Biopsy, Clinical Decision-Making, Computer Systems, Female, Humans, Male, Middle Aged, Practice Patterns, Physicians', Prospective Studies, Registries, Tomography, Optical Coherence, United States, Barrett's esophagus, dysplasia, endomicroscopy, imaging
Abstract

Volumetric laser endomicroscopy (VLE) uses optical coherence tomography (OCT) for real-time, microscopic cross-sectional imaging. A US-based multi-center registry was constructed to prospectively collect data on patients undergoing upper endoscopy during which a VLE scan was performed. The objective of this registry was to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics as they are applied to Barrett's esophagus (BE) management. All procedures utilized the NvisionVLE Imaging System (NinePoint Medical, Bedford, MA) which was used by investigators to identify the tissue types present, along with focal areas of concern. Following the VLE procedure, investigators were asked to answer six key questions regarding how VLE impacted each case. Statistical analyses including neoplasia diagnostic yield improvement using VLE was performed. One thousand patients were enrolled across 18 US trial sites from August 2014 through April 2016. In patients with previously diagnosed or suspected BE (894/1000), investigators used VLE and identified areas of concern not seen on white light endoscopy (WLE) in 59% of the procedures. VLE imaging also guided tissue acquisition and treatment in 71% and 54% of procedures, respectively. VLE as an adjunct modality improved the neoplasia diagnostic yield by 55% beyond the standard of care practice. In patients with no prior history of therapy, and without visual findings from other technologies, VLE-guided tissue acquisition increased neoplasia detection over random biopsies by 700%. Registry investigators reported that VLE improved the BE management process when used as an adjunct tissue acquisition and treatment guidance tool. The ability of VLE to image large segments of the esophagus with microscopic cross-sectional detail may provide additional benefits including higher yield biopsies and more efficient tissue acquisition. Clinicaltrials.gov NCT02215291.

Published
2019

8. SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications.

Author

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, and Yadav, Dhiraj

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Prevention, Digestive Diseases, Clinical Research, Oral and gastrointestinal, Adult, Cholangiopancreatography, Endoscopic Retrograde, Cholangiopancreatography, Magnetic Resonance, Cohort Studies, Endosonography, Female, Humans, Internationality, Male, Outcome Assessment, Health Care, Pancreas, Pancreatitis, Recurrence, Risk Factors, Secondary Prevention, Sphincterotomy, Endoscopic, acute pancreatitis, acute recurrent pancreatitis, chronic pancreatitis, endoscopic retrograde cholangiopancreatography, pancreas divisum, SHARP Consortium, Gastroenterology & Hepatology, Clinical sciences
Abstract

ObjectivesIn 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.MethodsThe SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 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 a maximum of 48 months.ResultsThe trial is powered to detect a 33% risk reduction of acute pancreatitis frequency.ConclusionsThe 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.

Published
2019

9. Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial

Author

Han, Samuel, Miley, Angelina, Akshintala, Venkata, Freeman, Martin L., Kahaleh, Michel, Othman, Mohamed, Patel, Sandeep, Papachristou, Georgios I., Raijman, Isaac, Sankey, Noel, Sayana, Hari, Singh, Vikesh, Tarnasky, Paul, Trikudanathan, Guru, and Shah, Raj J.

Published
2022
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11. Digital Cholangioscopic Interpretation: When North Meets the South

Author

Kahaleh, Michel, Raijman, Isaac, Gaidhane, Monica, Tyberg, Amy, Sethi, Amrita, Slivka, Adam, Adler, Douglas G., Sejpal, Divyesh, Shahid, Haroon, Sarkar, Avik, Martins, Fernanda, Boumitri, Christine, Burton, Samuel, Bertani, Helga, Tarnasky, Paul, Gress, Frank, Gan, Ian, Ardengh, Jose C., Kedia, Prashant, Arnelo, Urban, Jamidar, Priya, Shah, Raj J., and Robles-Medranda, Carlos

Published
2022
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14. An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction

Author

Elmunzer, B. Joseph, Smith, Zachary L., Tarnasky, Paul, Wang, Andrew Y., Yachimski, Patrick, Banovac, Filip, Buscaglia, Jonathan M., Buxbaum, James, Chak, Amitabh, Chong, Bradford, Coté, Gregory A., Draganov, Peter V., Dua, Kulwinder, Durkalski, Valerie, Geller, Brian S., Jamil, Laith H., Keswani, Rajesh N., Khashab, Mouen A., Law, Ryan, Lo, Simon K., McCarthy, Sean, Selby, J. Bayne, Singh, Vikesh K., Taylor, Jason R., Willingham, Field F., Spitzer, Rebecca L., and Foster, Lydia D.

Published
2021
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15. Individualized Pain Treatment in Chronic Pancreatitis (INPAIN): An International, Multicenter, Investigator-Initiated, Prospective, Cohort Study.

Author

Hagn-Meincke, Rasmus, Dugic, Ana, Agarwal, Ankit, Phillips, Anna Evans, Waage, Anna, Yadav, Dhiraj, Pillai, Divya, Vivian, Elaina, de-Madaria, Enrique, Niazi, Imran Khan, Easler, Jeffrey, Frøkjær, Jens Brøndum, McNabb-Baltar, Julia, Asferg, Louise Kuhlmann, Faghih, Mahya, Montiel, Maria Belen Garay, Cook, Mathias, Unnisa, Misbah, Tarnasky, Paul, and Hegyi, Peter

Published
2025
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17. First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study

Author

Amy Tyberg, Isaac Raijman, Monica Gaidhane, Arvind J. Trindade, Haroon Shahid, Avik Sarkar, Jason Samarasena, Iman Andalib, David L. Diehl, Douglas K. Pleskow, Kevin E. Woods, Stuart R. Gordon, Rahul Pannala, Prashant Kedia, Peter V. Draganov, Paul R. Tarnasky, Divyesh V. Sejpal, Nikhil A. Kumta, Gulshan Parasher, Douglas G. Adler, Kalpesh Patel, Dennis Yang, Uzma Siddiqui, Michel Kahaleh, and Viren Joshi

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

Published
2022
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18. Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial

Author

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, and Elmunzer, B Joseph

Published
2020
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19. Sphincterotomy for biliary sphincter of Oddi disorder and idiopathic acute recurrent pancreatitis: the RESPOnD longitudinal cohort

Author

Coté, Gregory A, Elmunzer, Badih Joseph, Nitchie, Haley, Kwon, Richard S, Willingham, Field, Wani, Sachin, Kushnir, Vladimir, Chak, Amitabh, Singh, Vikesh, Papachristou, Georgios I, Slivka, Adam, Freeman, Martin, Gaddam, Srinivas, Jamidar, Priya, Tarnasky, Paul, Varadarajulu, Shyam, Foster, Lydia D, and Cotton, Peter

Abstract

ObjectiveSphincter of Oddi disorders (SOD) are contentious conditions in patients whose abdominal pain, idiopathic acute pancreatitis (iAP) might arise from pressurisation at the sphincter of Oddi. The present study aimed to measure the benefit of sphincterotomy for suspected SOD.DesignProspective cohort conducted at 14 US centres with 12 months follow-up. Patients undergoing first-time endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy for suspected SOD were eligible: pancreatobiliary-type pain with or without iAP. The primary outcome was defined as the composite of improvement by Patient Global Impression of Change (PGIC), no new or increased opioids and no repeat intervention. Missing data were addressed by hierarchal, multiple imputation scheme.ResultsOf 316 screened, 213 were enrolled with 190 (89.2%) of these having a dilated bile duct, abnormal labs, iAP or some combination. By imputation, an average of 122/213 (57.4% (95% CI 50.4% to 64.4%)) improved; response rate was similar for those with complete follow-up (99/161, 61.5% (54.0% to 69.0%)); of these, 118 (73.3%) improved by PGIC alone. Duct size, elevated labs and patient characteristics were not associated with response. AP occurred in 37/213 (17.4%) at a median of 6 months post ERCP and was more likely in those with a history of AP (30.9% vs 2.9%, p<0.0001).ConclusionNearly 60% of patients undergoing ERCP for suspected SOD improve, although the contribution of a placebo response is unknown. Contrary to prevailing belief, duct size and labs are poor response predictors. AP recurrence was common and like observations from prior non-intervention cohorts, suggesting no benefit of sphincterotomy in mitigating future AP episodes.

Published
2025
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20. EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience

Author

Kumta, Nikhil A., Tyberg, Amy, Bhagat, Vicky H., Siddiqui, Ali A., Kowalski, Thomas E., Loren, David E., Desai, Amit P., Sarkisian, Alex M., Brown, Elizabeth G., Karia, Kunal, Gaidhane, Monica, Kedia, Prashant, Tarnasky, Paul R., Patel, Umangi, Adler, Douglas, Taylor, Linda J., Petrone, Maria, Arcidiacono, Paolo, Yachimski, Patrick S., Weine, Douglas, Sundararajan, Subha, Deprez, Pierre H., Mouradides, Christina, Ho, Sammy, Javed, Safeera, Easler, Jeffrey J., Raijman, Isaac, Vazquez-Sequeiros, Enrique, Sawhney, Mandeep, Berzin, Tyler M., and Kahaleh, Michel

Published
2019
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21. Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification

Author

Sethi, Amrita, Tyberg, Amy, Slivka, Adam, Adler, Douglas G., Desai, Amit P., Sejpal, Divyesh V., Pleskow, Douglas K., Bertani, Helga, Gan, Seng-Ian, Shah, Raj, Arnelo, Urban, Tarnasky, Paul R., Banerjee, Subhas, Itoi, Takao, Moon, Jong Ho, Kim, Dong Choon, Gaidhane, Monica, Raijman, Isaac, Peterson, Bret T., Gress, Frank G., and Kahaleh, Michel

Published
2022
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31. Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass

Author

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, B. 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., 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., and Draganov, Peter V.

Published
2018
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33. Optical coherence tomography of the pancreatic and bile ducts: are we ready for prime time?

Author

Amy Tyberg, Isaac Raijman, Aleksey A. Novikov, Divyesh V. Sejpal, Petros C. Benias, Arvind J. Trindade, Ananya Das, Mankanwal Sachdev, Farhoud Khosravi, Paul Tarnasky, Prashant Kedia, Monica Gaidhane, Michel Kahaleh, and Virendra Joshi

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background and study aims First-generation optical coherence tomography (OCT) has been shown to increase diagnostic sensitivity for malignant biliary and pancreatic-duct strictures. A newer OCT imaging system, NVision Volumetric Laser Endomicroscopy (VLE), allows for in vivo cross-sectional imaging of the ductal wall at the microstructure level during endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to identify and evaluate characteristics on OCT that are predictive of benign and malignant strictures. Patients and methods Consecutive patients from six centers who underwent OCT between September 2016 and September 2017 were included in a dedicated registry. OCT images were analyzed, and nine recurring characteristics were further assessed. Final diagnosis was based on histology and/or surgical pathology. Results 86 patients were included (49 % male, mean age 64.7). OCT was performed in the bile duct in 79 patients and the pancreatic duct in seven. Nine OCT characteristics were identified: dilated hypo-reflective structures (n = 7), onion-skin layering (n = 8), intact layering (n = 17), layering effacement (n = 25), scalloping (n = 20), thickened epithelium (n = 42), hyper-glandular mucosa (n = 13), prominent blood vessels (n = 6), and a hyper-reflective surface (n = 20). Presence of hyper-glandular mucosa, hyper-reflective surface and scalloping significantly increased the odds of malignancy diagnosis by 6 times more (P = 0.0203; 95 % CI 1.3 to 26.5), 4.7 times more (P = 0.0255; 95 % CI 1.2 to 18.0) and 7.9 times more (P = 0.0035; 95 % CI 1.97 to 31.8) respectively. Conclusion By providing in-vivo cross-sectional imaging of the pancreatic and biliary duct wall, OCT technology may improve sensitivity in diagnosing malignant strictures and provide standardizable criteria predictive of malignancy.

Published
2020
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36. Contributors

Author

Adler, Douglas G., primary, Ahlawat, Sushil K., additional, Ahmad, Jawad, additional, Al-Kawas, Firas H., additional, Anderson, Michelle A., additional, de Almeida Artifon, Everson Luiz, additional, de Andrade Lima Cabral, João Guilherme Guerra, additional, Baillie, John, additional, Banerjee, Rupa, additional, Baron, Todd H., additional, Basar, Omer, additional, Benias, Petros C., additional, Boškoski, Ivo, additional, Bourke, Michael J., additional, Brauer, Brian C., additional, Brugge, William R., additional, Buscaglia, Jonathan M., additional, Carr-Locke, David L., additional, Chahal, Prabhleen, additional, Chandran, Sujievvan, additional, Chen, Yen-I, additional, Choi, Anthony J., additional, Cohen, Jonah, additional, Costamagna, Guido, additional, Coté, Gregory A., additional, Cotton, Peter, additional, Das, Koushik K., additional, Devière, Jacques, additional, Edmundowicz, Steven A., additional, El Hajj, Ihab I., additional, Faigel, Douglas O., additional, Familiari, Pietro, additional, Fockens, Paul, additional, Fogel, Evan L., additional, Fox, Victor L., additional, Freeman, Martin L., additional, Gan, S. Ian, additional, Gelrud, Andres, additional, Ginsberg, Gregory G., additional, Gluck, Michael, additional, Goh, Khean-Lee, additional, Hawes, Robert H., additional, Higa, Jennifer T., additional, Holmes, Jordan D., additional, Irani, Shayan, additional, Itoi, Takao, additional, Jamidar, Priya A., additional, Kahaleh, Michel, additional, Kalloo, Anthony N., additional, Khashab, Mouen A., additional, Kochman, Michael L., additional, Kodama, Tadashi, additional, Korman, Andrew, additional, Kortan, Paul, additional, Koshitani, Tatsuya, additional, Kozarek, Richard A., additional, Larsen, Michael, additional, Lau, James Y.W., additional, Law, Ryan, additional, Lehman, Glen, additional, Leung, Joseph W., additional, Ligresti, Dario, additional, Lin, Eugene, additional, Lo, Simon K., additional, Ma, Michael X., additional, Maple, John T., additional, Mariani, Alberto, additional, May, Gary, additional, McHenry, Lee, additional, Mizrahi, Meir, additional, Mounzer, Rawad, additional, Muniraj, Thiruvengadam, additional, Neuhaus, Horst, additional, Norton, Ian D., additional, Perez-Miranda, Manuel, additional, Petersen, Bret T., additional, Pleskow, Douglas, additional, Purnak, Tugrul, additional, Rao, G. Venkat, additional, Razzak, Anthony, additional, Reddy, D. Nageshwar, additional, Ross, Andrew S., additional, Sarkisian, Alexander M., additional, Schueler, Beth, additional, Seo, Dong Wan, additional, Shah, Raj J., additional, Sharaiha, Reem Z., additional, Sherman, Stuart, additional, Shim, Chan Sup, additional, Singh, Ajaypal, additional, Slivka, Adam, additional, Solomon, Sanjeev, additional, Song, Tae Jun, additional, Srinivasan, Indu, additional, Sung, Joseph J.Y., additional, Tarantino, Ilaria, additional, Tarnasky, Paul R., additional, Testoni, Pier Alberto, additional, Tobin, Catherine D., additional, Topazian, Mark, additional, Wani, Sachin, additional, Wong, John C.T., additional, and Yen, Andrew W., additional

Published
2019
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38. Contributors

Author

Achord, James L., primary, Alfa, Michelle J., additional, Al-Haddad, Mohammad, additional, Anderloni, Andrea, additional, Anderson, Joseph C., additional, Baiges, Anna, additional, Baillie, John, additional, Barkun, Alan N., additional, Baron, Todd H., additional, Basar, Omer, additional, Benson, Mark, additional, Silva, Lyz Bezerra, additional, Bezobchuk, Stas, additional, Binmoeller, Kenneth F., additional, Blankstein, Sarah, additional, Blero, Daniel, additional, Bourke, Michael J., additional, Brugge, William R., additional, Bruno, Marco J., additional, Buchner, Anna M., additional, Cárdenas, Andrés, additional, Carr-Locke, David, additional, Chang, Kenneth, additional, Chawla, Saurabh, additional, Clarke, John O., additional, Cohen, Jonathan, additional, Copland, Andrew P., additional, Costamagna, Guido, additional, Cotton, Peter B., additional, Desai, Amit P., additional, Devière, Jacques, additional, DiMaio, Christopher J., additional, Draganov, Peter, additional, Dumortier, Jérôme, additional, Easler, Jeffrey J., additional, Falk, Gary W., additional, Farraye, Francis A., additional, Feld, Andrew, additional, Feld, Kayla, additional, Fockens, Paul, additional, Fogel, Evan L., additional, Fortinsky, Kyle J., additional, Freeman, Martin L., additional, Carlos, Juan, additional, Gerdes, Hans, additional, Gibson, Joanna A., additional, Ginsberg, Gregory G., additional, Giovannini, Marc, additional, Gralnek, Ian M., additional, Gress, Frank G., additional, Hawes, Robert H., additional, Hernández-Gea, Virginia, additional, Hirano, Ikuo, additional, Hochberger, Juergen, additional, Howell, Douglas A., additional, Hur, Chin, additional, Hwang, Joo Ha, additional, Ibáñez, Maite Betés, additional, Itoi, Takao, additional, Iyer, Prasad G., additional, Johnson, David A., additional, Jonnalagadda, Sreeni, additional, Kahi, Charles J., additional, Kaltenbach, Tonya, additional, Kia, Leila, additional, Kimmey, Michael B., additional, Klein, Amir, additional, Kochman, Michael L., additional, Kohli, Divyanshoo R., additional, Korman, Andrew, additional, Kwong, Wilson T., additional, Law, Ryan, additional, Leiman, David A., additional, Lennon, Anne Marie, additional, Levy, Michael, additional, Lichtenstein, David, additional, Lichtenstein, Gary R., additional, Likhitsup, Alisa, additional, Limdi, Jimmy K., additional, Lollo, Gianluca, additional, Maluf-Filho, Fauze, additional, Maranki, Jennifer, additional, McCallum, Richard W., additional, McClave, Stephen A., additional, Mergener, Klaus, additional, Metz, David C., additional, Meves, Volker, additional, Morris, Marcia L., additional, Mullady, Daniel K., additional, Muñoz-Navas, Miguel, additional, Muthusamy, V. Raman, additional, Nabi, Zaheer, additional, Nett, Andrew, additional, Nguyen, Nam Q., additional, Nickl, Nicholas, additional, Nonaka, Satoru, additional, Oda, Ichiro, additional, Odze, Robert D., additional, Oldfield, Edward C., additional, Parekh, Parth J., additional, Pfau, Patrick R., additional, Pioche, Mathieu, additional, Pohl, Heiko, additional, Ponchon, Thierry, additional, Ponec, Robert J., additional, Rajala, Michael W., additional, Reddy, Nageshwar, additional, Repici, Alessandro, additional, Rivory, Jérôme, additional, Ryou, Marvin, additional, Saito, Yutaka, additional, Samarasena, Jason B., additional, Savides, Thomas J., additional, Schoeman, Mark, additional, Schulman, Allison R., additional, Sethi, Amrita, additional, Shah, Pari M., additional, Sherman, Stuart, additional, Siddiqui, Uzma D., additional, Singh, Vikesh K., additional, Soetikno, Roy, additional, Stavropoulos, Stavros N., additional, Stevens, Tyler, additional, Surawicz, Christina, additional, Tanner, Barry, additional, Tarnasky, Paul, additional, Thompson, Christopher C., additional, Topazian, Mark, additional, Triadafilopoulos, George, additional, van Halsema, Emo E., additional, van Hooft, Jeanin E., additional, Vargo, John Joseph, additional, Visrodia, Kavel, additional, Wadhwa, Vaibhav, additional, Wall, Kristian, additional, Walsh, Catharine M., additional, Wang, Andrew Y., additional, Wang, Kenneth K., additional, Wani, Sachin, additional, Wilcox, C. Mel, additional, Willingham, Field F., additional, Yachimski, Patrick S., additional, and Zorron, Ricardo, additional

Published
2019
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41. Endoscopic retrograde cholangiopancreatography complications: Techniques to reduce risk and management strategies

Author

Paul R. Tarnasky and Prashant Kedia

Subjects
Cholangiopancreatography, endoscopic retrograde, Hemorrhage, Intestinal perforation, Pancreatitis, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and can be associated with tragic outcomes. Bleeding, perforation, and post-ERCP pancreatitis are the most common complications. Some events are unavoidable; others are associated with well described risk factors so that they can be either anticipated and/or measures can be taken for prevention or at least risk reduction. This review will focus on the more common complications after ERCP, their risk factors, and potential strategies for risk reduction. Additionally, recommendations for management of ERCP complications will be presented.

Published
2017
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42. Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use

Author

Jennifer L. Maranki, Steven D. Schwaitzberg, Reem Z. Sharaiha, Vladimir M. Kushnir, Dilhana S. Badurdeen, Vivek Kumbhari, Victoria Gómez, Nikhil A. Kumta, Jerome D. Waye, Jose Nieto, Michael B. Ujiki, Petros C. Benias, Larry S. Miller, Prashant Kedia, Paul Tarnasky, Abraham Mathew, John M. Levenick, Sumant Inamdar, Benjamin Tharian, Yanina Nersesova, Lydia Fredell, Sonya Serra, and Michael L. Kochman

Subjects
Sutures, Suture Techniques, Humans, Surgery, Obesity, Registries, Endoscopy, Gastrointestinal
Abstract

The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing.The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices.We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity.The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Published
2022
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44. LONG TERM EVALUATION OF THE SAFETY AND EFFICACY OF ENDOSCOPIC DIRECT TRANSGASTRIC ERCP (EDGE)

Author

Tyberg, Amy, primary, Sarkar, Avik, additional, Shahid, Haroon, additional, Miller, Dillon, additional, Pelton, Matt, additional, Vazquez-Sequeiros, Enrique, additional, Gornals, Joan, additional, Gjeorgjievski, Mihajlo, additional, Abdelqader, Abdelhai, additional, Tarnasky, Paul, additional, Braun, David, additional, Lee, David, additional, Chalikonda, Divya, additional, Bilello, Justin, additional, Schlachterman, Alexander, additional, Kumar, Anand, additional, Chiang, Austin, additional, Kowalski, Thomas, additional, Loren, David, additional, Zitun, Mohamed, additional, Thakkar, Shyam, additional, Kedia, Prashant, additional, Gaidhane, Monica, additional, and Kahaleh, Michel, additional

Published
2023
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50. Mobile Application to Identify Cancer Treatment–Related Financial Assistance: Results of a Randomized Controlled Trial

Author

Ian Manners, Fred A P Friedman, George Tran, Jakob Oury, Steven Wolf, Kanan Shah, S. Yousuf Zafar, Kathryn I. Pollak, Jillian C. Thompson, Ben Gagosian, Jonathan Nicolla, Aaron Tarnasky, Anthony D. Sung, and Jesse D. Troy

Subjects
Finance, Oncology (nursing), business.industry, Health Policy, MEDLINE, Middle Aged, Mobile Applications, law.invention, Cancer treatment, 03 medical and health sciences, 0302 clinical medicine, Oncology, Randomized controlled trial, law, Neoplasms, Surveys and Questionnaires, 030220 oncology & carcinogenesis, Income, Humans, Medicine, 030212 general & internal medicine, Health Expenditures, business
Abstract

PURPOSE: Insured patients with cancer face high treatment-related, out-of-pocket (OOP) costs and often cannot access financial assistance. We conducted a randomized, controlled trial of Bridge, a patient-facing app designed to identify eligible financial resources for patients. We hypothesized that patients using Bridge would experience greater OOP cost reduction than controls. METHODS: We enrolled patients with cancer who had OOP expenses from January 2018 to March 2019. We randomly assigned patients 1:1 to intervention (Bridge) versus control (financial assistance educational websites). Primary and secondary outcomes were self-reported OOP costs and subjective financial distress 3 months postenrollment. In post hoc analyses, we analyzed application for and receipt of financial assistance at 3 months postenrollment. We used chi-square, Mann-Whitney tests, and logistic regression to compare study arms. RESULTS: We enrolled 200 patients. The median age was 57 years (IQR, 47.0-63.0). Most patients had private insurance (71%), and the median household income was $62,000 in US dollars (USD) (IQR, $36,000-$100,000 [USD]). Substantial missing data precluded assessment of primary and secondary outcomes. In post hoc analyses, patients in the Bridge arm were more likely than controls to both apply for and receive financial assistance. CONCLUSION: We were unable to test our primary outcome because of excessive missing follow-up survey data. In exploratory post hoc analyses, patients who received a financial assistance app were more likely to apply for and receive financial assistance. Ultimately, our study highlights challenges faced in identifying measurable outcomes and retaining participants in a randomized, controlled trial of a mobile app to alleviate financial toxicity.

Published
2021
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