304 results on '"Raj J. Shah"'
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2. Endoscopic treatment of a refractory benign biliary stricture using cholangioscopy-guided thulium laser stricturoplasty
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Paul A. Leonor, MD, Angelina Miley, BS, Abdullah Al-Shahrani, MD, and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2022
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3. Pancreatoscopy-guided laser dissection of obstructing pancreatic duct stricture: pancreas-preserving endotherapy
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Emily R. Jonica, MD and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2022
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4. Benefit of endoscopic stenting for dominant strictures in patients with primary sclerosing cholangitis
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Samuel Han and Raj J. Shah
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and study aims Dominant strictures (DS) occur in up to 60 % of patients with primary sclerosing cholangitis (PSC). Data regarding the long-term effects of stenting vs. dilation remain limited. The aim of this study was to compare the two treatment modalities in terms of transplantation-free survival. Patients and methods This single-center, retrospective study examined patients with PSC and DS treated endoscopically with a minimum of 1 year follow-up. Patients were divided into two cohorts: 1) those who received dilation alone; and 2) those who received both dilation and stenting. The primary outcome was transplantation-free survival, defined as time after index ERCP to liver transplantation. Results In all, 169 patients (54 in dilation cohort, 115 in stenting cohort) were included. The stenting cohort had a significantly higher Mayo PSC Risk Score (1.8 ± 1.1 vs. 0.9 ± 1.2) and presented with cholangitis more frequently (22.6 % vs. 1.9 %). During a follow-up period of 1198 person-years, 69 (40.8 %) patients received transplantation at a mean of 3.4 (± 2.9) years. There was no difference in transplantation rate in the stenting cohort [68 (95 % CI 5.2–8.8) per 100 person-years] compared to the dilation cohort [3.7 (95 % CI 2.1–6.0) per 100 person-years] and no difference in risk for transplantation (dilation cohort adjusted hazards ratio 0.67, 95 % CI 0.33–1.32). Conclusions Despite a higher Mayo Risk Score in the stenting group, there was no difference in transplantation-free survival between patients managed with stenting vs. dilation alone. Stenting, therefore, may offer benefit in patients with advanced PSC and DS.
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- 2022
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5. Pancreatoscopy-guided retrieval of a migrated pancreatic duct stent
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Abdullah A. Al-Shahrani, MD, Eric Swei, MD, Sachin Wani, MD, and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2022
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6. An adverse event of EUS-directed transgastric ERCP: stent-in-stent technique to bridge the peritoneal gap
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Anna Duloy, MD, Hazem Hammad, MD, and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2019
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7. Cholangiopancreatoscopy-guided laser dissection and ablation for pancreas and biliary strictures and neoplasia
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Samuel Han and Raj J. Shah
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and study aims Cholangiopancreatoscopy-guided laser dissection or ablation (CPL) is a novel therapeutic modality for refractory benign strictures. Our aim was to describe the safety and efficacy of CPL for pancreaticobiliary disorders. Patients and methods Patients who underwent CPL using holmium or thulium laser between February 2017 and September 2019 were included. For stricture dissection, gentle strokes of the laser fiber from a distal to proximal approach were applied until luminal patency permitted advancement of the cholangiopancreatoscope. Immediate technical success was defined as ability to traverse the stricture with the cholangiopancreatoscope after CPL. Short-term technical success was defined as > 90 % resolution of the stricture on follow-up pancreatogram. Results Eleven patients underwent a mean of 3.6 ERCPs (mean total diameter of 14.2 Fr of stenting) prior to CPL. Indications included pancreatic duct stricture (n = 8), pancreaticojejunostomy anastomotic stricture (n = 1), bile duct stricture (n = 1) and pancreatic intraductal papillary mucinous neoplasm ablation (n = 1). Immediate technical success was 94.1 % and short-term technical success rates was 88.2 %. At a mean follow-up of 12.1 months, there have been no stricture recurrences. Conclusions CPL may be an effective therapy for strictures refractory to conventional dilation and multiple stenting.
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- 2020
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8. Laser dissection for recalcitrant pancreaticojejunostomy anastomotic stricture
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Samuel Han, MD and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2019
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9. Response: Emerging uses of cholangioscopy for choledocholithiasis
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Samuel Han, MD and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2020
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10. Cholangioscopy-guided basket retrieval of impacted stones
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Samuel Han, MD and Raj J. Shah, MD
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2020
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11. Safety and efficacy of digital single-operator pancreatoscopy for obstructing pancreatic ductal stones
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Olaya I. Brewer Gutierrez, Isaac Raijman, Raj J. Shah, B. Joseph Elmunzer, George J.M. Webster, Douglas Pleskow, Stuart Sherman, Richard P. Sturgess, Divyesh V. Sejpal, Christopher Ko, Attilio Maurano, Douglas G. Adler, Daniel K. Mullady, Daniel S. Strand, Christopher J. DiMaio, Cyrus Piraka, Reem Sharahia, Mohamad H. Dbouk, Samuel Han, Clayton M. Spiceland, Noor L.H. Bekkali, Moamen Gabr, Benjamin Bick, Laura K. Dwyer, Dennis Han, James Buxbaum, Claudio Zulli, Natalie Cosgrove, Andrew Y. Wang, David Carr-Locke, Tossapol Kerdsirichairat, Hanaa Dakour Aridi, Robert Moran, Shawn Shah, Juliana Yang, Omid Sanaei, Nasim Parsa, Vivek Kumbhari, Vikesh K. Singh, and Mouen A. Khashab
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and study aims The role of the digital single-operator pancreatoscopy (D-SOP) with electrohydraulic (EHL) or laser lithotripsy (LL) in treating pancreatic ductal stones is unclear. We investigated the safety and efficacy of D-SOP with EHL or LL in patients with obstructing pancreatic duct stones. Patients and methods Retrospective analysis of 109 patients who underwent D-SOP for pancreatic stones at 17 tertiary centers in the United States and Europe from February 2015 to September 2017. Logistic regression was performed to identify factors associated with the need for more than one D-SOP with EHL/LL. Results Most patients were males (70.6 %),mean age 54.7 years. Fifty-nine (54.1 %) underwent EHL and 50 (45.9 %) underwent LL. Mean procedure time was longer in the EHL group (74.4 min vs 53.8 min; P
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- 2019
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12. Randomized study of digital single-operator cholangioscope compared to fiberoptic single-operator cholangioscope in a novel cholangioscopy bench model
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Raj J. Shah, Horst Neuhaus, Mansour Parsi, D. Nageshwar Reddy, and Douglas K. Pleskow
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and study aims Cholangiopancreatoscopy is utilized for diagnosis and therapy of pancreaticobiliary disorders. a fully-disposable, digital, single-operator cholangioscope (DSOC) was developed with high image resolution and wide field-of-view. This bench study compared the new DSOC to the previous semi-disposable, fiber-optic cholangioscope (FSOC) prior to the clinical availability of the DSOC system. Methods Five experts performed one practice run followed by randomized runs comparing DSOC to FSOC in a biliary tract model consisting of three fixed left-intrahepatic tracts (LIHD), and variable common bile duct (CBD) and right-intrahepatic tracts (RIHD) with seven total lesions in multiple configurations. Timed runs aimed to visualize and target each lesion using miniature biopsy forceps. Definitions: visual success, visualizing targets; targeting success, touching target with forceps; complete run, touching seven targets within 20 minutes. Image quality, ease-of-use, and time to completion were recorded. Results Thirty-seven evaluable runs (20 DSOC, 17 FSOC) were completed. DSOC was superior to FSOC in Visual (99 % vs. 67 %, P
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- 2018
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13. A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
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Bret T. Petersen, Michel Kahaleh, Richard A. Kozarek, David Loren, Kapil Gupta, Thomas Kowalski, Martin Freeman, Yang K. Chen, Malcolm S. Branch, Steven Edmundowicz, Michael Gluck, Kenneth Binmoeller, Todd H. Baron, Raj J. Shah, Timothy Kinney, William Ross, Paul Jowell, and David Carr-Locke
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.
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- 2013
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14. Potential Peripheral Biomarkers for the Diagnosis of Alzheimer's Disease
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Seema Patel, Raj J. Shah, Paul Coleman, and Marwan Sabbagh
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 ,Geriatrics ,RC952-954.6 - Abstract
Advances in the discovery of a peripheral biomarker for the diagnosis of Alzheimer's would provide a way to better detect the onset of this debilitating disease in a manner that is both noninvasive and universally available. This paper examines the current approaches that are being used to discover potential biomarker candidates available in the periphery. The search for a peripheral biomarker that could be utilized diagnostically has resulted in an extensive amount of studies that employ several biological approaches, including the assessment of tissues, genomics, proteomics, epigenetics, and metabolomics. Although a definitive biomarker has yet to be confirmed, advances in the understanding of the mechanisms of the disease and major susceptibility factors have been uncovered and reveal promising possibilities for the future discovery of a useful biomarker.
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- 2011
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15. Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis
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Vinay Chandrasekhara, Joyce Peetermans, Hazem T. Hammad, Ambreen A. Merchant, Andrew C. Storm, Sachin Wani, Mohammad Al Haddad, Mark A. Gromski, Mihir S. Wagh, Jeffrey J. Easler, Stuart Sherman, Barham K. Abu Dayyeh, Bret T. Petersen, Edmund McMullen, John A. Martin, Field F. Willingham, John M. DeWitt, Steven A. Edmundowicz, Michael J. Levy, Mark Topazian, Ornela Gjata, Raj J. Shah, Benjamin L. Bick, and Naoki Takahashi
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medicine.medical_specialty ,business.industry ,Multicenter trial ,medicine.medical_treatment ,Walled off necrosis ,Medicine ,Stent ,Lumen (anatomy) ,Surgery ,Drainage ,business - Abstract
We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.Randomized trials have shown similar efficacy of endoscopic treatment compared to surgery for infected WON.We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound (EUS)-guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥ 6 cm in diameter with 30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events (SAEs).Forty consecutive patients were enrolled September 2018 - March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. SAEs occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.EUS-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.gov no: NCT03525808.
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- 2023
16. Clinical Outcomes and Patency after Transjugular Intrahepatic Portosystemic Shunt Reduction for Overshunting Adverse Events
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Raj J. Shah, Murad M. Alqadi, Madhavi Duvvuri, Yoon-Jin Kim, Ravi Tyagi, R. Peter Lokken, and Ron C. Gaba
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Male ,End Stage Liver Disease ,Treatment Outcome ,Hepatic Encephalopathy ,Hypertension, Portal ,Humans ,Female ,Radiology, Nuclear Medicine and imaging ,Middle Aged ,Portasystemic Shunt, Transjugular Intrahepatic ,Cardiology and Cardiovascular Medicine ,Severity of Illness Index ,Retrospective Studies - Abstract
To assess clinical outcomes and patency after transjugular intrahepatic portosystemic shunt (TIPS) reduction for overshunting adverse events.This multicenter, retrospective observational study included 33 patients (male-to-female ratio, 20:13; mean age, 59 years; mean Model for End-Stage Liver Disease [MELD] score, 15) who underwent TIPS reduction between 2007 and 2020. Procedure indications included medically refractory hepatic encephalopathy (HE) (85%), post-TIPS hepatic insufficiency (HI) (12%), and heart failure (3%). The measured outcomes included improvement in HE (classified using the West Haven system) and HI, patency of reduced TIPS, and transplant-free survival (TFS).TIPS reductions were successfully performed using parallel stent (94%) or other (6%) techniques at a median of 120 days after TIPS creation (HE, median, 164 days; HI, median, 5 days). The portosystemic pressure gradient increased from a mean of 10 to 17 mm Hg (P.001). The overall HE rate after TIPS reduction was 54%; HE was persistent, improved, and resolved in 21%, 32%, and 46% cases, respectively. In patients with HI, the MELD score increased from a mean of 22 before TIPS to 34 after TIPS (P = .061), but without improvement (0%) in HI after TIPS reduction (mean MELD score, 30; P = .266). Recurrent ascites occurred in 14% of the patients. The median shunt patency was 961 days (95% confidence interval, 476-1,447). The 30-day, 6-month, 1-year, and 3-year shunt patency rates were 92%, 81%, 74%, and 37%, respectively. The median TFS was not reached. The 30-day, 6-month, 1-year, and 3-year survival rates were 97%, 90%, 81%, and 60%, respectively.Although TIPS reduction may be an effective and durable approach to treat post-TIPS medically refractory HE, shunt reduction may not achieve meaningful benefit for HI.
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- 2022
17. Future of Cholangioscopy
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Jorge D, Machicado, Isaac, Raijman, and Raj J, Shah
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Cholangiopancreatography, Endoscopic Retrograde ,Artificial Intelligence ,Gastroenterology ,Humans - Abstract
This article highlights the current status of cholangioscopy. In addition, the authors present their view on the future directions of cholangioscopy, including novel clinical applications, the need for technologic developments, and the expansion on the use of cholangioscopy in clinical practice. The authors envision that cholangioscopy will eventually become a conventional tool in the shelf of any biliary endoscopist. Future technologic improvements including optics, maneuverability, and full device accessories, plus the introduction of real-time artificial intelligence algorithms, will optimize the outcomes of cholangioscopy, but baseline proficiency in therapeutic endoscopic retrograde cholangiopancreatography will remain necessary for its successful utilization.
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- 2022
18. EUS-guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis: A Prospective Multicenter Trial
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Shayan S. Irani, Neil R. Sharma, Andrew C. Storm, Raj J. Shah, Prabhleen Chahal, Field F. Willingham, Lee Swanstrom, Todd H. Baron, Eran Shlomovitz, Richard A. Kozarek, Joyce A. Peetermans, Edmund McMullen, Evelyne Ho, and Schalk W. van der Merwe
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Surgery - Abstract
To evaluate the safety and efficacy endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS).For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage (PT-GBD).We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the USA and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30-to-60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs).Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including 1 fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS.For select patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to PT-GBD. It has high technical and clinical success, with low recurrence and an acceptable adverse event rate. Clinicaltrials.gov, Number: NCT03767881.
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- 2022
19. Effect of pancreatic endotherapy on quality of life in chronic pancreatitis patients: A systematic review
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Raj J. Shah, Samuel Y Han, Georgios I. Papachristou, and Darwin L. Conwell
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Quality of life ,medicine.medical_specialty ,Endoscopic retrograde cholangiopancreatography ,medicine.diagnostic_test ,Systematic Reviews ,business.industry ,medicine.disease ,Gastroenterology ,Internal medicine ,Medicine ,Pancreatitis ,Pancreatic endotherapy ,business ,Chronic pancreatitis - Abstract
BACKGROUND Pancreatic endotherapy provides treatment options for the management of chronic pancreatitis-related structural complications such as pancreatic duct stones, strictures, and pancreatic fluid collections. Most studies detailing endotherapy, however, have focused on technical success outcomes such as stone clearance or stricture resolution. AIM To review the effect of pancreatic endotherapy on patient-centered outcomes. METHODS Systematic review of studies examining pancreatic endotherapy. RESULTS A total of 13 studies including 3 randomized clinical trials were included. The majority of studies found an improvement in quality of life with pancreatic endotherapy. CONCLUSION While pancreatic endotherapy does appear to improve quality of life, there are clear gaps in knowledge regarding many pancreatic endotherapy modalities. Furthermore, qualitative analysis is lacking in these studies and further work is needed to elucidate the patient experience with pancreatic endotherapy.
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- 2021
20. Direct Endoscopic Necrosectomy With and Without Hydrogen Peroxide for Walled-off Pancreatic Necrosis: A Multicenter Comparative Study
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B. Joseph Elmunzer, Ahmed A. Messallam, Dan Mullady, Thomas Hollander, Qiang Cai, Satish Nagula, Chao Zhang, Nikhil A. Kumta, Linda J. Taylor, Madeleine Birch, Steven Tsistrakis, Steven Keilin, Michael Oliver M. Mercado, Field F. Willingham, Harkirat Singh, Samuel Han, Gregory A. Cote, Christopher J. DiMaio, Natalie Cosgrove, Robert A. Moran, Georgios I. Papachristou, Huma Javaid, Jose Nieto, Mohamed O. Othman, Douglas G. Adler, Raj J. Shah, and Nicolas LaBarre
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Male ,medicine.medical_specialty ,Necrosis ,Clinical success ,Endosonography ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Endoscopy, Digestive System ,Retrospective Studies ,Hepatology ,medicine.diagnostic_test ,Pancreatitis, Acute Necrotizing ,business.industry ,Gastroenterology ,Retrospective cohort study ,Hydrogen Peroxide ,Odds ratio ,Middle Aged ,medicine.disease ,Surgery ,Endoscopy ,Treatment modality ,030220 oncology & carcinogenesis ,Anti-Infective Agents, Local ,Drainage ,Pancreatitis ,Female ,030211 gastroenterology & hepatology ,medicine.symptom ,business ,Complication ,Follow-Up Studies - Abstract
Endoscopic necrosectomy has emerged as the preferred treatment modality for walled-off pancreatic necrosis. This study was designed to evaluate the safety and efficacy of direct endoscopic necrosectomy with and without hydrogen peroxide (H2O2) lavage.Retrospective chart reviews were performed for all patients undergoing endoscopic transmural management of walled-off pancreatic necrosis at 9 major medical centers from November 2011 to August 2018. Clinical success was defined as the resolution of the collection by imaging within 6 months, without requiring non-endoscopic procedures or surgery.Of 293 patients, 204 met the inclusion criteria. Technical and clinical success rates were 100% (204/204) and 81% (166/189), respectively. For patients, 122 (59.8%) patients had at least one H2O2 necrosectomy (H2O2 group) and 82 (40.2%) patients had standard endoscopic necrosectomy. Clinical success was higher in the H2O2 group: 106/113 (93.8%) vs 60/76 (78.9%), P = 0.002. On a multivariate analysis, the use of H2O2 was associated with higher clinical success rate (odds ratio 3.30, P = 0.033) and earlier resolution (odds ratio 2.27, P0.001). During a mean follow-up of 274 days, 27 complications occurred. Comparing procedures performed with and without H2O2 (n = 250 vs 183), there was no difference in post-procedure bleeding (7 vs 9, P = 0.25), perforation (2 vs 3, P = 0.66), infection (1 vs 2, P = 0.58), or overall complication rate (n = 13 [5.2%] vs 14 [7.7%], P = 0.30).H2O2-assisted endoscopic necrosectomy had a higher clinical success rate and a shorter time to resolution with equivalent complication rates relative to standard necrosectomy.See the visual abstract at http://links.lww.com/AJG/B714.(Equation is included in full-text article.).
- Published
- 2020
21. Cholangiopancreatoscopy-guided laser dissection and ablation for pancreas and biliary strictures and neoplasia
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Raj J. Shah and Samuel Han
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Original article ,medicine.medical_specialty ,Intraductal papillary mucinous neoplasm ,business.industry ,Bile duct ,medicine.medical_treatment ,Technical success ,Anastomosis ,Ablation ,medicine.disease ,Surgery ,medicine.anatomical_structure ,Pancreatic duct stricture ,medicine ,Laser fiber ,lcsh:Diseases of the digestive system. Gastroenterology ,Pharmacology (medical) ,lcsh:RC799-869 ,Pancreas ,business - Abstract
Background and study aims Cholangiopancreatoscopy-guided laser dissection or ablation (CPL) is a novel therapeutic modality for refractory benign strictures. Our aim was to describe the safety and efficacy of CPL for pancreaticobiliary disorders. Patients and methods Patients who underwent CPL using holmium or thulium laser between February 2017 and September 2019 were included. For stricture dissection, gentle strokes of the laser fiber from a distal to proximal approach were applied until luminal patency permitted advancement of the cholangiopancreatoscope. Immediate technical success was defined as ability to traverse the stricture with the cholangiopancreatoscope after CPL. Short-term technical success was defined as > 90 % resolution of the stricture on follow-up pancreatogram. Results Eleven patients underwent a mean of 3.6 ERCPs (mean total diameter of 14.2 Fr of stenting) prior to CPL. Indications included pancreatic duct stricture (n = 8), pancreaticojejunostomy anastomotic stricture (n = 1), bile duct stricture (n = 1) and pancreatic intraductal papillary mucinous neoplasm ablation (n = 1). Immediate technical success was 94.1 % and short-term technical success rates was 88.2 %. At a mean follow-up of 12.1 months, there have been no stricture recurrences. Conclusions CPL may be an effective therapy for strictures refractory to conventional dilation and multiple stenting.
- Published
- 2020
22. Combination of ERCP-Based Modalities Increases Diagnostic Yield for Biliary Strictures
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Samuel Han, Sachin Wani, Hazem T. Hammad, Mihir S. Wagh, Sanjana Mehrotra, Raj J. Shah, Brian C. Brauer, Steven A. Edmundowicz, Philip D. Tatman, and Augustin Attwell
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Confocal laser endomicroscopy ,medicine.medical_specialty ,medicine.diagnostic_test ,Physiology ,business.industry ,Brush cytology ,Gastroenterology ,Hepatology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Dysplasia ,030220 oncology & carcinogenesis ,Internal medicine ,Biopsy ,Medicine ,%22">Fish ,030211 gastroenterology & hepatology ,Sampling (medicine) ,business ,Nuclear medicine ,Forceps biopsy - Abstract
Biliary stricture evaluation with brush cytology and intraductal forceps biopsy carries a low sensitivity, but the combination of newer modalities may improve sensitivity. To determine whether the addition of advanced modalities increases diagnostic yield of ERCP-based sampling. This single-center retrospective study evaluates patients with biliary strictures sampled using brush cytology. Operating characteristics were calculated for individual and combinations of modalities including cholangioscopy, fluoroscopy- and cholangioscopy-directed intraductal biopsy, fluorescence in situ hybridization (FISH), and confocal laser endomicroscopy. Analyses under Standard Criteria (SC) included malignant results as “positive” and Expanded Criteria (EC) included “suspicious” and “high-grade dysplasia” results as “positive.” A total of 614 patients were included, and 354 (57.8%) received brush cytology alone, which had a sensitivity of 38.5% (SC) to 40.3% (EC) and a specificity of 97.8% (EC) to 99.3% (SC). Combining brush cytology with fluoroscopy-guided biopsy (n = 259, 42.2%) had a sensitivity of 62.5% (SC) to 67.9% (EC) and specificity of 90.2% (EC) to 96.7% (SC). Adding FISH to brush cytology had a sensitivity of 84.2% (SC) to 87.5% (EC) and specificity of 54.1% (SC and EC), while cholangioscopy visualization addition resulted in a sensitivity of 80.4% (SC) to 92.2% (EC) and specificity of 67.3% (EC) to 89.1% (SC). There were no significant differences in sensitivity and specificity using SC and EC. Brush cytology has a low sensitivity, but the addition of other modalities increases sensitivity. There was no difference in specificity between the SC and the EC, supporting the inclusion of “suspicious” impressions with malignant results at our center.
- Published
- 2020
23. Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures
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Takao Itoi, Raj J. Shah, Amrita Sethi, Subhas Banerjee, Helga Bertani, Michel Kahaleh, Douglas G. Adler, Jong Ho Moon, Douglas K. Pleskow, Isaac Raijman, Seng-Ian Gan, Frank G. Gress, Adam Slivka, Dong Choon Kim, Amit P. Desai, Divyesh V. Sejpal, Paul R. Tarnasky, Amy Tyberg, Monica Gaidhane, Bret T. Peterson, and Urban Arnelo
- Subjects
Observer Variation ,Visual impression ,medicine.medical_specialty ,Cholestasis ,business.industry ,Gastroenterology ,Presumptive diagnosis ,Diagnostic accuracy ,Constriction, Pathologic ,Classification ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,medicine ,Humans ,030211 gastroenterology & hepatology ,Radiology ,CLIPS ,Indeterminate ,business ,computer ,computer.programming_language - Abstract
Background Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. Materials and methods In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. Results In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. Conclusions The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.
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- 2020
24. Choledochoduodenostomy is associated with fewer post-transplant biliary complications compared to Roux-en-Y in primary sclerosing cholangitis patients
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Emily R. Jonica, Samuel Han, James R. Burton, James J. Pomposelli, and Raj J. Shah
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Cholangiopancreatography, Endoscopic Retrograde ,Transplantation ,Postoperative Complications ,Treatment Outcome ,Cholangitis ,Choledochostomy ,Cholangitis, Sclerosing ,Living Donors ,Humans ,Anastomosis, Roux-en-Y ,Retrospective Studies - Abstract
For primary sclerosing cholangitis (PSC) patients undergoing liver transplantation (LT), a consensus regarding biliary reconstruction remains unresolved. Choledochoduodenostomy (CDD) represents an alternative to Roux-en-Y (RY) and duct-to-duct. We compared long-term post-transplant outcomes between CDD and RY.This was a retrospective review of patients transplanted for PSC who received CDD or RY, with minimum 12-months follow-up. The primary outcome was need for biliary intervention, with either percutaneous transhepatic cholangiography (PTC) or endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes included biliary stricture(s) and cholangitis admission(s).Ninety-three patients were transplanted between August 2004 and October 2019 (34 living donor [LDLT] and 59 deceased donor [DDLT]; 40 RY, 53 CDD). Need for either ERCP or PTC was similar (45.0% RY vs. 32.1% CDD, P = .203), though RY exhibited more anastomotic strictures (AS) (35.0% RY vs. 11.3% CDD, P = .006), which was also observed in LDLT subanalyses (50.0% LDLT/RY vs. 10.0% LDLT/CDD; P = .036). Cholangitis admissions were more frequent in RY versus CDD (37.5% vs. 15.1%, P = .013).CDD does not impart greater risk of biliary complications, and RY may have an incremental effect combined with LDLT status for predisposing to AS. CDD maintains standard endoscopic access without additional risk of biliary complications, thus should be considered when anatomically feasible.
- Published
- 2021
25. S1093 Assessment of Physical and Mental Health Before and After Protocolized Endoscopic Necrosectomy for Walled-Off Pancreatic Necrosis in a Prospective Multi-Center Trial
- Author
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Ambreen Anil Merchant, Barham Abu Dayyeh, Vinay Chandrasekhara, Raj J. Shah, Jeffrey J. Easler, Andrew C. Storm, Mark D. Topazian, Michael J. Levy, John A. Martin, Bret T Petersen, Naoki Takahashi, Steven A. Edmundowicz, Mihir S. Wagh, Sachin Wani, John DeWitt, Mark A. Gromski, Mohammad Al-Haddad, Stuart Sherman, Joy Peetermans, Ornela Gjata, Margaret Gourlay, Edmund McMullen, and Field F. Willingham
- Subjects
Hepatology ,Gastroenterology - Published
- 2022
26. Electrocautery-enhanced Lumen-apposing Metal Stents in the Management of Symptomatic Pancreatic Fluid Collections: Results From the Multicenter Prospective Pivotal Trial
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David E. Loren, Raj J. Shah, Parit Mekaroonkamol, Jose Nieto, Mouen A. Khashab, Field F. Willingham, Steven A. Edmundowicz, and Irving Waxman
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Stent ,Lumen (anatomy) ,Investigational device exemption ,Surgery ,Clinical trial ,Multicenter trial ,Clinical endpoint ,medicine ,Fluoroscopy ,Adverse effect ,business - Abstract
BACKGROUND AND AIMS Endoscopic decompression is considered a first-line treatment for symptomatic pancreatic fluid collections (PFCs). A lumen-apposing metal stent (LAMS) with an electrocautery-enhanced delivery system [electrocautery-enhanced lumen-apposing metal stent (ELAMS)] may facilitate this procedure. This study evaluated the safety and efficacy of ELAMS in the management of symptomatic PFCs. PATIENTS AND METHODS A multicenter, nonblinded, prospective, Food and Drug Administration (FDA)-approved, investigational device exemption clinical trial was conducted. Enrollment criteria included symptomatic PFCs ≥6 cm with ≥70% fluid fraction. Subjects were followed prospectively for safety, efficacy, and resolution of the collections. Primary endpoint success was defined as ≥50% reduction in PFC size. Clinical outcomes were compared with our previously published series of LAMS without the cautery-enhanced delivery system. RESULTS The target enrollment of 30 patients was achieved in 7 US tertiary care centers. All patients underwent successful placement of the ELAMS. The mean procedure duration, stent placement time, and fluoroscopy exposures were 28.1±12.5, 5.8±2.6, and 1.8±1.6 minutes, respectively. Eight patients had no fluoroscopy. The primary endpoint was achieved in 83.3% of patients. Two adverse events were attributed to the ELAMS: 1 bleeding upon stent removal and 1 stent migration. Relative to the comparator noncautery LAMS multicenter trial (N=33, 8 tertiary centers), there was a significantly shorter procedure duration [36 min (P
- Published
- 2021
27. No flare(s), no problem: treating recalcitrant pancreatic duct strictures with short fully covered metal stents
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Raj J. Shah and Samuel Han
- Subjects
Pancreatic duct ,medicine.medical_specialty ,business.industry ,Pancreatic Ducts ,Gastroenterology ,Constriction, Pathologic ,law.invention ,medicine.anatomical_structure ,Metals ,law ,medicine ,Humans ,Stents ,Radiology, Nuclear Medicine and imaging ,Radiology ,business ,Flare - Published
- 2020
28. Safety and efficacy of digital single-operator pancreatoscopy for obstructing pancreatic ductal stones
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Samuel Han, Claudio Zulli, Christopher J. DiMaio, Natalie Cosgrove, George Webster, Divyesh V. Sejpal, Robert A. Moran, Juliana Yang, Reem Sharahia, Hanaa Dakour Aridi, Daniel Mullady, Vivek Kumbhari, Richard Sturgess, Moamen Gabr, Tossapol Kerdsirichairat, Shawn L. Shah, Mohamad Dbouk, Nasim Parsa, Cyrus Piraka, Olaya I. Brewer Gutierrez, James Buxbaum, B. Joseph Elmunzer, David L. Carr-Locke, Raj J. Shah, Laura K. Dwyer, Noor Bekkali, Vikesh K. Singh, Douglas K. Pleskow, Stuart Sherman, Daniel S. Strand, A. Maurano, Christopher Ko, Douglas G. Adler, Dennis Han, Omid Sanaei, Isaac Raijman, Andrew Y. Wang, Mouen A. Khashab, Clayton M. Spiceland, and Benjamin L. Bick
- Subjects
Pancreatic duct ,medicine.medical_specialty ,Original article ,business.industry ,medicine.medical_treatment ,Mean age ,Laser lithotripsy ,3. Good health ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,medicine ,030211 gastroenterology & hepatology ,Pharmacology (medical) ,Pancreatic stones ,In patient ,lcsh:Diseases of the digestive system. Gastroenterology ,Pancreatic carcinoma ,lcsh:RC799-869 ,business ,Procedure time - Abstract
Background and study aims The role of the digital single-operator pancreatoscopy (D-SOP) with electrohydraulic (EHL) or laser lithotripsy (LL) in treating pancreatic ductal stones is unclear. We investigated the safety and efficacy of D-SOP with EHL or LL in patients with obstructing pancreatic duct stones. Patients and methods Retrospective analysis of 109 patients who underwent D-SOP for pancreatic stones at 17 tertiary centers in the United States and Europe from February 2015 to September 2017. Logistic regression was performed to identify factors associated with the need for more than one D-SOP with EHL/LL. Results Most patients were males (70.6 %),mean age 54.7 years. Fifty-nine (54.1 %) underwent EHL and 50 (45.9 %) underwent LL. Mean procedure time was longer in the EHL group (74.4 min vs 53.8 min; P Conclusion D-SOP with EHL or LL is effective and safe in patients with pancreatic ductal stones.
- Published
- 2019
29. ENDOSCOPIC CLEARANCE OF NON-COMPLEX BILE DUCT STONES USING FLUOROSCOPY-FREE DIRECT SINGLE-OPERATOR CHOLANGIOSCOPY: INITIAL MULTI-CENTER EXPERIENCE
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Wiriyaporn Ridtitid, Rungsun Rerknimitr, Mohan K. Ramchandani, Sundeep Lakhtakia, Raj J. Shah, Janak Shah, Nirav Thosani, Mahesh K. Goenka, Guido Costamagna, Mihir S. Wagh, Vincenzo Perri, Joyce A. Peetermans, Pooja Goswamy, Zoe Liu, Elizabeth Kennedy, Srey Yin, and Subhas Banerjee
- Subjects
Gastroenterology ,Radiology, Nuclear Medicine and imaging - Published
- 2022
30. Individual probe based confocal laser endomicroscopy criteria in the analysis of indeterminate biliary strictures
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Michael Dubow, Raj J. Shah, and Philip D. Tatman
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Adult ,Male ,medicine.medical_specialty ,Constriction, Pathologic ,Sensitivity and Specificity ,Primary sclerosing cholangitis ,Cholangiocarcinoma ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Aged ,Cholangiopancreatography, Endoscopic Retrograde ,Confocal laser endomicroscopy ,Microscopy, Confocal ,business.industry ,Gastroenterology ,Middle Aged ,Tissue sampling ,medicine.disease ,Bile Ducts, Intrahepatic ,Bile Duct Neoplasms ,ROC Curve ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Regression Analysis ,Female ,030211 gastroenterology & hepatology ,Radiology ,business ,Indeterminate - Abstract
Evaluation of indeterminate biliary strictures remains challenging due to limited sensitivity of endoscopic tissue sampling. Biliary probe-based confocal laser endomicroscopy (pCLE) has shown promise to detect and exclude neoplasia. However, knowledge of whether individual inflammatory criteria are more prevalent in neoplasia compared to benign strictures is limited. The objective of this work is to improve diagnosis of neoplastic and inflammatory conditions using pCLE.The charts of all patients who underwent pCLE at a single referral center between 2009 and 2015 were reviewed. ERCP reports were reviewed for eleven Miami and Paris criteria. Primary outcome was the identification of neoplasia by histopathology (defined as high-grade dysplasia and/or adenocarcinoma). To model predictors of neoplasia, we fit a binary regression model incorporating data from pCLE operating criteria, pCLE impression, and PSC status.97 patients were identified. In the 27 patients with neoplasia, there was increasing number of Miami malignant criteria (Pearson r = 0.512, p .001) while inflammatory criteria were less prevalent. 10% (5/51, p .001) of patients with benign pCLE impression developed neoplasia, while 48% (22/46, p .001) with suspicious pCLE impressions developed neoplasia. The binary regression model to predict neoplasia had a sensitivity of 83.3%, specificity of 92.5%, and overall accuracy 89.7%.Presence of malignant criteria and absence of certain inflammatory criteria are more prevalent in patients with neoplasia. Our model, which weights individual imaging components, shows impressive sensitivity and specificity over prior prognostic efforts. Prospective studies will be required to evaluate this model.
- Published
- 2018
31. Impact of Radiation Dose on Postoperative Complications in Esophageal and Gastroesophageal Junction Cancers
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Christopher H. Lieu, Megan D. Marsh, Karyn A. Goodman, William T. Purcell, Noah Kastelowitz, Alexis D. Leal, Steven A. Edmundowicz, Tracey E. Schefter, Priscilla K. Stumpf, Martin D. McCarter, Raj J. Shah, S. Lindsey Davis, Christopher D. Scott, Sachin Wani, Hazem T. Hammad, Madeleine A. Kane, Narine Wandrey Bhardwaj, Robert A. Meguid, Michael J. Weyant, Stephen Leong, Wells A. Messersmith, and John D. Mitchell
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Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Gastroesophageal Junction ,lcsh:RC254-282 ,gastro-esophageal junction cancer ,Tomotherapy ,03 medical and health sciences ,0302 clinical medicine ,medicine ,esophageal cancer ,Stage (cooking) ,chemoradiation ,radiotherapy ,Original Research ,business.industry ,Cancer ,Esophageal cancer ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Radiation therapy ,Oncology ,Esophagectomy ,030220 oncology & carcinogenesis ,esophagectomy ,030211 gastroenterology & hepatology ,Radiology ,business ,Complication - Abstract
Introduction: The impact of radiation prescription dose on postoperative complications during standard of care trimodality therapy for operable stage II-III esophageal and gastroesophageal junction cancers has not been established.Methods: We retrospectively reviewed 82 patients with esophageal or gastroesophageal junction cancers treated between 2004 and 2016 with neoadjuvant chemoradiation followed by resection at a single institution. Post-operative complications within 30 days were reviewed and scored using the Comprehensive Complication Index (CCI). Results were compared between patients treated with Results: Twenty-nine patients were treated with Conclusions: In selected esophageal and gastroesophageal junction cancer patients, radiation doses ≥ 50 Gy do not appear to increase 30 day post-operative complication rates. These findings suggest that the use of definitive doses of radiotherapy (50–50.4 Gy) in the neoadjuvant setting may not increase post-operative complications.
- Published
- 2021
32. Adverse Events Associated With Therapeutic Endoscopic Retrograde Pancreatography
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Mihir S. Wagh, Hazem T. Hammad, Samuel Han, Augustin Attwell, Steven A. Edmundowicz, Philip D. Tatman, Sachin Wani, and Raj J. Shah
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Adult ,Male ,Abdominal pain ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Perforation (oil well) ,Article ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Pancreatectomy ,Postoperative Complications ,Risk Factors ,Internal medicine ,Internal Medicine ,Medicine ,Humans ,Endoscopy, Digestive System ,Adverse effect ,Pancreas ,Aged ,Retrospective Studies ,Pancreatic duct ,Endoscopic retrograde cholangiopancreatography ,Hepatology ,medicine.diagnostic_test ,business.industry ,Pancreatic Ducts ,Retrospective cohort study ,Odds ratio ,Middle Aged ,medicine.disease ,medicine.anatomical_structure ,Logistic Models ,Pancreatitis ,030220 oncology & carcinogenesis ,Multivariate Analysis ,030211 gastroenterology & hepatology ,Female ,medicine.symptom ,business - Abstract
Objectives Data regarding the safety of endoscopic retrograde pancreatography (ERP) are limited compared with biliary endoscopic retrograde cholangiopancreatography. The aim of this study was to determine adverse events (AEs) associated with therapeutic ERP. Methods This single-center retrospective study examined consecutive therapeutic ERPs with the primary intention of cannulating the pancreatic duct. Multivariate logistic regression was performed to identify risk factors for AEs. Results A total of 3023 ERPs were performed in 1288 patients (mean age, 50.3 years; 57.8% female) from January 2000 to January 2017. Overall AE rate was 18.9% with abdominal pain requiring admission (9.8%) and post-ERP pancreatitis (5.7%) being most common. On multivariate analysis, female sex (adjusted odds ratio [aOR], 2.3; 95% confidence interval [CI], 1.9-2.9), acute recurrent pancreatitis (aOR, 5.0; 95% CI, 1.7-15.3), chronic pancreatitis (aOR, 1.8; 95% CI, 1.3-2.6), and pancreatic sphincter of Oddi dysfunction (aOR, 2.1; 95% CI, 1.4-3.3) were associated with an increased risk of overall AEs. Pancreatic sphincterotomy (aOR, 1.9; 95% CI, 1.5-2.4) and therapeutic stenting (aOR, 1.6; 95% CI, 1.2-2.2) also increased the risk of AEs. Conclusions Nearly 1 in 5 patients who undergo therapeutic ERP will experience an AE; however, the rates of major AEs, including post-ERP pancreatitis, bleeding, and perforation, are low.
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- 2021
33. Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial
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Raj J. Shah, Samuel Han, Virendra Joshi, Amrita Sethi, Adam Slivka, Michel Kahaleh, Reem Z. Sharaiha, Jennifer Chennat, Divyesh V. Sejpal, Prashant Kedia, and Paul R. Tarnasky
- Subjects
Male ,medicine.medical_specialty ,Cholangitis, Sclerosing ,Constriction, Pathologic ,Sensitivity and Specificity ,Primary sclerosing cholangitis ,Cholangiocarcinoma ,Biopsy ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Prospective cohort study ,Cholangiopancreatography, Endoscopic Retrograde ,Microscopy, Confocal ,Common bile duct ,medicine.diagnostic_test ,business.industry ,Lasers ,Gastroenterology ,Middle Aged ,medicine.disease ,Confidence interval ,Clinical trial ,medicine.anatomical_structure ,Bile Ducts, Intrahepatic ,Common hepatic duct ,Bile Duct Neoplasms ,Female ,Radiology ,business ,Left Hepatic Duct - Abstract
Background and Aims Patients with primary sclerosing cholangitis (PSC) and dominant biliary strictures carry increased risk for the development of cholangiocarcinoma. Although ERCP-based techniques including brush cytology and intraductal biopsy sampling represent first-line tissue sampling methods for dominant strictures, sensitivity is low. Probe-based confocal laser endomicroscopy (pCLE) offers microscopic-level imaging of subepithelial biliary mucosa. Because data regarding the use of pCLE in PSC are limited, we aimed to investigate its diagnostic performance in dominant strictures. Methods This was a multicenter prospective study involving PSC patients with dominant strictures. ERCP with pCLE was performed with use of the Miami classification (2+ criteria for malignant diagnosis) and Paris classification. Final malignant diagnoses required histopathologic confirmation, and benign diagnoses required a minimum of 1 year of follow-up without development of cancer. Results Fifty-nine patients (mean age, 49 years; 59% men) with 63 strictures were included in the study. Stricture locations included the common bile duct (31.7%), bifurcation (22.2%), and common hepatic duct (19%). Seven patients (11.9%) were found to have cholangiocarcinoma. The sensitivity and specificity of pCLE was 85.7% (95% confidence interval [CI], 42.1-99.6) and 73.1% (95% CI, 58.9-84.4), respectively. Within specific stricture locations, the highest sensitivity was seen at the bifurcation (100%; 95% CI, 2.5-100) and the right hepatic duct (100%; 95% CI, 29.2-100). The lowest sensitivities were seen at the common bile duct (25%; 95% CI, 5.5-57.2) and the left hepatic duct (28.6%; 95% CI, 3.7-70.9). Conclusions In this prospective multicenter study, pCLE had a high sensitivity in detecting cholangiocarcinoma, but technical aspects of the probe may limit evaluation in the common bile duct and left hepatic duct. Further evaluation is needed to elucidate the role of pCLE in the algorithm of excluding neoplasia in biliary strictures associated with PSC. (Clinical trial registration number: NCT02736708.)
- Published
- 2020
34. ID: 3520602 ENDOSCOPIC VS PERCUTANEOUS MANAGEMENT OF POST-TRANSPLANT BILIARY STRICTURES IN PRIMARY SCLEROSING CHOLANGITIS PATIENTS
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Samuel Han, Emily R. Jonica, and Raj J. Shah
- Subjects
medicine.medical_specialty ,Percutaneous ,business.industry ,Gastroenterology ,medicine ,Radiology, Nuclear Medicine and imaging ,medicine.disease ,business ,Post transplant ,Primary sclerosing cholangitis ,Surgery - Published
- 2021
35. Combination of ERCP-Based Modalities Increases Diagnostic Yield for Biliary Strictures
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Samuel, Han, Philip, Tatman, Sanjana, Mehrotra, Sachin, Wani, Augustin R, Attwell, Steven A, Edmundowicz, Brian C, Brauer, Mihir S, Wagh, Hazem T, Hammad, and Raj J, Shah
- Subjects
Adult ,Cholangiopancreatography, Endoscopic Retrograde ,Male ,Cholestasis ,Microscopy, Confocal ,Cytodiagnosis ,Constriction, Pathologic ,Adenocarcinoma ,Middle Aged ,Pancreatic Neoplasms ,Bile Duct Neoplasms ,Humans ,Female ,In Situ Hybridization, Fluorescence ,Aged ,Retrospective Studies - Abstract
Biliary stricture evaluation with brush cytology and intraductal forceps biopsy carries a low sensitivity, but the combination of newer modalities may improve sensitivity.To determine whether the addition of advanced modalities increases diagnostic yield of ERCP-based sampling.This single-center retrospective study evaluates patients with biliary strictures sampled using brush cytology. Operating characteristics were calculated for individual and combinations of modalities including cholangioscopy, fluoroscopy- and cholangioscopy-directed intraductal biopsy, fluorescence in situ hybridization (FISH), and confocal laser endomicroscopy. Analyses under Standard Criteria (SC) included malignant results as "positive" and Expanded Criteria (EC) included "suspicious" and "high-grade dysplasia" results as "positive."A total of 614 patients were included, and 354 (57.8%) received brush cytology alone, which had a sensitivity of 38.5% (SC) to 40.3% (EC) and a specificity of 97.8% (EC) to 99.3% (SC). Combining brush cytology with fluoroscopy-guided biopsy (n = 259, 42.2%) had a sensitivity of 62.5% (SC) to 67.9% (EC) and specificity of 90.2% (EC) to 96.7% (SC). Adding FISH to brush cytology had a sensitivity of 84.2% (SC) to 87.5% (EC) and specificity of 54.1% (SC and EC), while cholangioscopy visualization addition resulted in a sensitivity of 80.4% (SC) to 92.2% (EC) and specificity of 67.3% (EC) to 89.1% (SC). There were no significant differences in sensitivity and specificity using SC and EC.Brush cytology has a low sensitivity, but the addition of other modalities increases sensitivity. There was no difference in specificity between the SC and the EC, supporting the inclusion of "suspicious" impressions with malignant results at our center.
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- 2019
36. An adverse event of EUS-directed transgastric ERCP: stent-in-stent technique to bridge the peritoneal gap
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Raj J. Shah, Hazem T. Hammad, and Anna Duloy
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medicine.medical_specialty ,LAMS, lumen apposing metal stent ,business.industry ,medicine.medical_treatment ,Gastroenterology ,EDGE, EUS-directed transgastric ERCP ,Medicine ,Stent ,Radiology, Nuclear Medicine and imaging ,business ,Video Case Report ,Bridge (interpersonal) ,Surgery - Published
- 2019
37. Randomized study of digital single-operator cholangioscope compared to fiberoptic single-operator cholangioscope in a novel cholangioscopy bench model
- Author
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Mansour A. Parsi, Raj J. Shah, Douglas K. Pleskow, Horst Neuhaus, and D. Nageshwar Reddy
- Subjects
medicine.medical_specialty ,Original article ,Bench model ,Image quality ,business.industry ,Forceps ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,030220 oncology & carcinogenesis ,medicine ,030211 gastroenterology & hepatology ,Pharmacology (medical) ,lcsh:Diseases of the digestive system. Gastroenterology ,Radiology ,Completion time ,lcsh:RC799-869 ,business ,Biopsy forceps - Abstract
Background and study aims Cholangiopancreatoscopy is utilized for diagnosis and therapy of pancreaticobiliary disorders. a fully-disposable, digital, single-operator cholangioscope (DSOC) was developed with high image resolution and wide field-of-view. This bench study compared the new DSOC to the previous semi-disposable, fiber-optic cholangioscope (FSOC) prior to the clinical availability of the DSOC system. Methods Five experts performed one practice run followed by randomized runs comparing DSOC to FSOC in a biliary tract model consisting of three fixed left-intrahepatic tracts (LIHD), and variable common bile duct (CBD) and right-intrahepatic tracts (RIHD) with seven total lesions in multiple configurations. Timed runs aimed to visualize and target each lesion using miniature biopsy forceps. Definitions: visual success, visualizing targets; targeting success, touching target with forceps; complete run, touching seven targets within 20 minutes. Image quality, ease-of-use, and time to completion were recorded. Results Thirty-seven evaluable runs (20 DSOC, 17 FSOC) were completed. DSOC was superior to FSOC in Visual (99 % vs. 67 %, P Conclusions In this model, DSOC performed superiorly to FSOC in image quality, visualization, and maneuverability. The model could potentially be utilized for training endoscopists less experienced with cholangiopancreatoscopy.
- Published
- 2018
38. Gastrointestinal Endoscopy Editorial Board top 10 topics: advances in GI endoscopy in 2017
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Kondal R. Kyanam Kabir Baig, Raj J. Shah, Felix W. Leung, Lee L. Swanstrom, Girish Mishra, Joo Ha Hwang, David J. Desilets, Amitabh Chak, and Jennifer Maranki
- Subjects
Adenoma ,Natural Orifice Endoscopic Surgery ,medicine.medical_specialty ,Endoscopic Mucosal Resection ,Per-oral endoscopic myotomy ,Colonic Polyps ,Editorial board ,Gi endoscopy ,Endoscopy, Gastrointestinal ,Endosonography ,Barrett Esophagus ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Obesity ,Gastrointestinal endoscopy ,Microscopy, Confocal ,medicine.diagnostic_test ,business.industry ,General surgery ,Gastroenterology ,Obesity Surgery ,Disease Management ,Colonoscopy ,Endoscopic submucosal dissection ,Inflammatory Bowel Diseases ,medicine.disease ,Endoscopy ,Disinfection ,Surgery, Computer-Assisted ,030220 oncology & carcinogenesis ,Barrett's esophagus ,Equipment Contamination ,Stents ,030211 gastroenterology & hepatology ,Journal Impact Factor ,Pancreatic Cyst ,Periodicals as Topic ,Colorectal Neoplasms ,business ,Myotomy - Published
- 2018
39. Advanced ERCP techniques for the extraction of complex biliary stones: a single referral center’s 12-year experience
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Nicholas G. Brown, Brian C. Brauer, Eric Nordstrom, Roy D. Yen, Stuart K. Amateau, Sachin Wani, Joel Camilo, Augustin Attwell, Norio Fukami, and Raj J. Shah
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Male ,medicine.medical_specialty ,Colorado ,Databases, Factual ,medicine.medical_treatment ,Gallstones ,Lithotripsy ,Balloon ,Catheterization ,Hospitals, University ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Aged ,Retrospective Studies ,Aged, 80 and over ,Cholangiopancreatography, Endoscopic Retrograde ,business.industry ,Gastroenterology ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Dilatation ,Laser lithotripsy ,Surgery ,Treatment Outcome ,Cholecystectomy, Laparoscopic ,Pancreatitis ,030220 oncology & carcinogenesis ,Referral center ,Female ,030211 gastroenterology & hepatology ,business ,BILIARY STONES - Abstract
Advanced ERCP techniques (AETs) for difficult biliary stones include peroral cholangioscopy (POC) with electrohydraulic/laser lithotripsy (EHL/LL), endoscopic papillary large balloon dilation (EPLBD) and mechanical lithotripsy (ML). We assess the efficacy of AETs.A retrospective query for AETs.Complete duct clearance. Secondary outcome: Complete duct clearance by technique. Statistical Analysis version 9.3 (SAS Inc., Cary, NC).From 1/00 to 10/12, 349 patients were identified of which 222 (80% had prior ERCPs) had AETs. 211 with sufficient follow-up underwent 295 ERCPs; 280 of which were AET's. Index AETs: POC with EHL/LL (n = 46/211, 22%), ML (n = 84/211, 40%), EPLBD with mean balloon size of 11.5 ± 1.7 mm (n = 39/211, 18%) and combination AETs (n = 42/211, 20%). Stone characteristics: 76% had ≥1 stone, 81% extrahepatic and 32% had strictures. Number of stones (mean 2.5 and range 1-20) did not differ among groups. EPLBD had higher percentage (95%) of extrahepatic stones (p = .0003). The 'Combination' and 'POC' groups had larger stones (mean 17.7 mm ±6.4 and 16.8 mm ±6.1, respectively; p .001). Complete clearance: 209/211 (99%) at index AET 167/211 (79%) or after mean of 2.5 ± 0.7 AETs in 42/211 (20%). Partial clearance: 2/211 (1%). Clearance at index AETs was higher with EPLBD (90%, p = .014). Adverse Events: 7/280 (2.5%).AETs achieved clearance in 99%. EPLBD had higher clearance at index AET likely owing to higher extrahepatic stones. Larger stones, but not number, were associated with increased combination AETs and total ERCPs.
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- 2018
40. Response: Emerging uses of cholangioscopy for choledocholithiasis
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Raj J. Shah and Samuel Han
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medicine.medical_specialty ,business.industry ,Gastroenterology ,Medicine ,Radiology, Nuclear Medicine and imaging ,Medical physics ,business ,Letter to the Editor - Published
- 2020
41. Dysplastic progression of a choledochal cyst on video cholangioscopy
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Benjamin W. Warren, Samuel Han, and Raj J. Shah
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medicine.medical_specialty ,business.industry ,Gastroenterology ,MEDLINE ,Anastomosis, Roux-en-Y ,medicine.disease ,Biliary Tract Surgical Procedures ,Choledochal Cyst ,Humans ,Medicine ,Laparoscopy ,Choledochal cysts ,Radiology ,business - Published
- 2020
42. ID: 3523615 PANCREATIC ENDOTHERAPY IMPROVES QUALITY OF LIFE AND PAIN IN PATIENTS WITH CHRONIC PANCREATITIS
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Samuel Han, Angelina Miley, Raj J. Shah, and Steven A. Edmundowicz
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medicine.medical_specialty ,Quality of life ,business.industry ,Internal medicine ,Gastroenterology ,medicine ,Pancreatitis ,Radiology, Nuclear Medicine and imaging ,In patient ,business ,medicine.disease - Published
- 2021
43. Cholangioscopy and pancreatoscopy
- Author
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Raj J. Shah and Amrita Sethi
- Subjects
medicine.medical_specialty ,Endoscopic retrograde cholangiopancreatography ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Tissue sampling ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,medicine ,030211 gastroenterology & hepatology ,Radiology, Nuclear Medicine and imaging ,Medical physics ,Radiology ,Therapeutic intent ,business - Abstract
Cholangiopancreatoscopy has evolved significantly since its introduction over 40 years ago. The systems have gone through multiple iterations that has allowed for widespread performance of per-oral cholangiopancreatoscopy for diagnostic and therapeutic intent. Development of imaging criteria is evolving and its yield in the detection of neoplasia in conjunction with targeted tissue sampling is excellent. However, image interpretation remains a challenge. Guidelines for training in per-oral cholangiopancreatoscopy, as well as demonstration of competency, are currently lacking but require deliberate debate as the technology continues to gather enthusiasm and momentum as an established complement to endoscopic retrograde cholangiopancreatography.
- Published
- 2017
44. Role of per-oral pancreatoscopy in the evaluation of suspected pancreatic duct neoplasia: a 13-year U.S. single-center experience
- Author
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Brian C. Brauer, Raj J. Shah, Augustin Attwell, Norio Fukami, Sachin Wani, and Ihab I. El Hajj
- Subjects
Adult ,Male ,Natural Orifice Endoscopic Surgery ,medicine.medical_specialty ,genetic structures ,Constriction, Pathologic ,Adenocarcinoma ,Single Center ,behavioral disciplines and activities ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Carcinoma ,Humans ,Radiology, Nuclear Medicine and imaging ,Endoscopy, Digestive System ,Adverse effect ,Aged ,Cholangiopancreatography, Endoscopic Retrograde ,Pancreatic duct ,Intraductal papillary mucinous neoplasm ,medicine.diagnostic_test ,urogenital system ,business.industry ,Pancreatic Ducts ,Gastroenterology ,Middle Aged ,medicine.disease ,Adenocarcinoma, Mucinous ,Occult ,United States ,Endoscopy ,Pancreatic Neoplasms ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,Radiology ,business ,psychological phenomena and processes ,Carcinoma, Pancreatic Ductal - Abstract
Background and Aims The role of per-oral pancreatoscopy (POP) in the evaluation of occult pancreatic duct (PD) lesions remains limited to case series. The aim of this study was to evaluate the ability of POP to differentiate malignant from benign diseases of the PD. Methods Patients who underwent POP between 2000 and 2013 for the evaluation of indeterminate PD strictures, dilatations, or with suspected or known main duct intraductal papillary mucinous neoplasm were identified. Main outcome measurements were visual impression accuracy, POP tissue sampling, efficacy, and safety of POP. Results During the study period, 79 patients who underwent POP for the evaluation of pancreatic stricture or dilatation were identified. Technical success was achieved in 78 (97%). In the PD neoplasia group (n = 33), the final diagnosis was based on index confirmatory POP-guided tissue sampling in 29 (88%). For the detection of PD neoplasia, POP visual impression had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 87%, 86%, 83%, 91%, and 87%, respectively. When combined with POP-guided tissue sampling, the values were 91%, 95%, 94%, 93%, and 94%, respectively. Of 102 POPs performed, adverse events were noted in 12 (12%) cases. Conclusions This study demonstrates a high technical success rate, visual impression accuracy, and tissue sampling capability of POP. Examinations were performed by endoscopists with expertise in pancreatoscopy interpretation, and the results may not be generalizable.
- Published
- 2017
45. Minor papilla endotherapy in patients with ventral duct obstruction: identification and management
- Author
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Sachin Wani, John Walker, Brian C. Brauer, Raj J. Shah, Douglas A. Howell, and Nicholas G. Brown
- Subjects
Adult ,Male ,Abdominal pain ,medicine.medical_specialty ,Adolescent ,Narcotic ,medicine.medical_treatment ,Constriction, Pathologic ,Catheterization ,Constriction ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pancreatitis, Chronic ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Child ,Aged ,Retrospective Studies ,Aged, 80 and over ,Cholangiopancreatography, Endoscopic Retrograde ,Pancreatic duct ,medicine.diagnostic_test ,business.industry ,Pancreatic Ducts ,Gastroenterology ,Pancreatic Diseases ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Dilatation ,Endoscopy ,Surgery ,Major duodenal papilla ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Pancreatitis ,Female ,Stents ,030211 gastroenterology & hepatology ,medicine.symptom ,business - Abstract
Background and Aims Pancreatic duct (PD) cannulation via the major papilla may be compromised by downstream obstruction of the ventral PD from a stone or stricture. In patients with a patent accessory PD, cannulation of the minor papilla permits stenting or stone removal upstream of the ventral PD obstruction. Data on this technique are limited. Methods University of Colorado Hospital and Maine Medical Center endoscopy databases were queried for ERCPs with minor papilla cannulation. Technical success was defined as deep cannulation of the minor papilla. Minor papilla endotherapy included sphincterotomy, stricture dilation, stenting, or stone treatment. Clinical improvement was designated as >50% reduction in pain or narcotic analgesia. Follow-up was obtained by chart review and telephone contact. Results Over a 22-year period, 464 patients had minor papilla cannulation. Congenital and incomplete pancreas divisum were excluded, and 64 patients met study criteria. Technical success was achieved in 58 of 64 patients (91%). In patients with stones, 25 of 34 (74%) had clearance using endoscopic techniques. Median follow-up was 15.5 months. Twelve of 28 patients (43%) on chronic narcotic regimens reported a reduction in narcotic use by >50%, and 32 of 44 patients (73%) reached for discussion noted improved abdominal pain by >50%. Thirteen patients required surgery for symptom control. Conclusions In this multicenter experience, 15% of patients undergoing minor papilla cannulation had acquired a ventral PD obstruction. Access via the minor papilla to the upstream main PD for endotherapy and clinical improvement was achieved in most patients. Increased and early recognition of these intensive therapeutic options may enhance treatment options for this complex group of patients.
- Published
- 2017
46. Su1287 TIMING OF DIRECT ENDOSCOPIC NECROSECTOMY THROUGH LUMEN-APPOSING METAL STENTS FOR WALLED-OFF PANCREATIC NECROSIS IMPACTS TIME TO RESOLUTION
- Author
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Raj J. Shah, Mihir S. Wagh, Steven A. Edmundowicz, Benjamin W. Warren, Hazem T. Hammad, Augustin Attwell, Samuel Han, and Sachin Wani
- Subjects
medicine.medical_specialty ,Necrosis ,business.industry ,Gastroenterology ,medicine ,Lumen (anatomy) ,Radiology, Nuclear Medicine and imaging ,Radiology ,medicine.symptom ,business - Published
- 2020
47. Su1268 A MULTICENTER INTERNATIONAL STUDY COMPARING CLINICAL OUTCOMES OF EUS-GUIDED GASTROJEJUNOSTOMY, SURGICAL GASTROJEJUNOSTOMY, AND ENTERAL STENTING FOR PATIENTS WITH GASTRIC OUTLET OBSTRUCTION
- Author
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Maridi Aerts, Veeravich Jaruvongvanich, Meher Oberoi, Neil B. Marya, Vinay Chandrasekhara, Samuel Han, Michael J. Levy, Andrew C. Storm, Louis M. Wong Kee Song, Raj J. Shah, Lovekirat Dhaliwal, Navtej S. Buttar, M. Phillip Fejleh, Karan Kaura, Mark J. Truty, Reem Matar, V. Raman Muthusamy, Barham K. Abu Dayyeh, Tarek Sawas, and Rastislav Kunda
- Subjects
medicine.medical_specialty ,business.industry ,Gastroenterology ,Medicine ,Radiology, Nuclear Medicine and imaging ,Gastric outlet obstruction ,business ,medicine.disease ,Enteral administration ,Surgery - Published
- 2020
48. In Memoriam: Brian C. Brauer, MD, FASGE (September 4, 1973, to September 7, 2019)
- Author
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Hazem T. Hammad, Mihir S. Wagh, Sachin Wani, Raj J. Shah, Lorena Johnson, Katie Dickerman, Augustin Attwell, and Steven A. Edmundowicz
- Subjects
business.industry ,Gastroenterology ,Medicine ,Radiology, Nuclear Medicine and imaging ,Theology ,business - Published
- 2020
49. 2 Hydrogen Peroxide-Assisted Endoscopic Necrosectomy vs. Standard Endoscopic Necrosectomy for Walled-Off Pancreatic Necrosis: A Multi-Center Retrospective Comparative Study
- Author
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Satish Nagula, Daniel Mullady, Natalie Cosgrove, Field F. Willingham, Huma Javaid, Robert A. Moran, Jose Nieto, Badih Joseph Elmunzer, Madeleine Birch, Nikhil A. Kumta, Linda J. Taylor, Raj J. Shah, Ahmed A. Messallam, Michael Oliver M. Mercado, Samuel Han, Steven Keilin, Georgios I. Papachristou, Nicolas LaBarre, Harkirat Singh, Thomas Hollander, Steven Tsistrakis, Mohamed O. Othman, Christopher J. DiMaio, Douglas G. Adler, Sarah Cristofaro, and Qiang Cai
- Subjects
medicine.medical_specialty ,chemistry.chemical_compound ,Necrosis ,Hepatology ,chemistry ,business.industry ,Gastroenterology ,medicine ,medicine.symptom ,business ,Hydrogen peroxide ,Surgery - Published
- 2019
50. 73 A PROSPECTIVE MULTICENTER STUDY EVALUATING EUS AND ERCP COMPETENCE DURING ADVANCED ENDOSCOPY TRAINING AND SUBSEQUENT INDEPENDENT PRACTICE: THE RAPID ASSESSMENT OF TRAINEE ENDOSCOPY SKILLS (RATES2) STUDY
- Author
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Sachin B. Wani, Rajesh N. Keswani, Matt Hall, Samuel Han, Eva Aagaard, Violette C. Simon, Linda Carlin, Swan Ellert, Wasif M. Abidi, Todd H. Baron, Brian C. Brauer, Hemant Chatrath, Gregory A. Cote, Koushik K. Das, Christopher J. DiMaio, Steven A. Edmundowicz, Ihab I. El Hajj, Hazem T. Hammad, Sujai Jalaj, Michael L. Kochman, Sri Komanduri, Linda S. Lee, Daniel Mullady, V. Raman Muthusamy, Andrew S. Nett, Mojtaba S. Olyaee, Kavous Pakseresht, Pranith Perera, Patrick Pfau, Cyrus Piraka, Amit Rastogi, Raj J. Shah, Rishi Sharma, James M. Scheiman, James H. Tabibian, Dushant Uppal, Shiro Urayama, Andrew Y. Wang, Tobias Zuchelli, Erik Bowman, Gabriel Lang, David E. Loren, Abdul Hamid El Chafic, Patrick Yachimski, Anthony Gamboa, John M. Poneros, Wahid Wassef, Muhammad Sohail, Tyler Stevens, Bradley Confer, Nalini M. Guda, S. Ian Gan, Anthony Razzak, Stuart R. Gordon, Jason Ferriera, Subhas Banerjee, Abhishek Choudhary, Andrew M. Dries, Jonathan M. Buscaglia, Demetrios Tzimas, Sergio Zepeda-Gomez, Sana Kenshil, Frank Lukens, Michael Bartel, Paul Jowell, Joshua P. Spaete, Brian Riff, Cynthia Harris, Shreyas Saligram, Bhargava Gannavarapu, Amitabh Chak, Ajaypal Singh, and Dayna Early
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,Multicenter study ,business.industry ,Gastroenterology ,Medicine ,Radiology, Nuclear Medicine and imaging ,Medical physics ,Independent practice ,business ,Competence (human resources) ,Endoscopy ,Rapid assessment - Published
- 2018
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