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Comparing EUS-Fine Needle Aspiration and EUS-Fine Needle Biopsy for Solid Lesions: A Multicenter, Randomized Trial

Nagula, Satish; Pourmand, Kamron; Aslanian, Harry; Bucobo, Juan Carlos; Gonda, Tamas; Gonzalez, Susana; Goodman, Adam; Gross, Seth A; Ho, Sammy; DiMaio, Christopher J; Kim, Michelle; Pais, Shireen; Poneros, John; Robbins, David; Schnoll-Sussman, Felice; Sethi, Amrita; Buscaglia, Jonathan M
BACKGROUND & AIMS: Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) is the standard of care for tissue sampling of solid lesions adjacent to the GI tract. Fine needle biopsy (FNB) may provide higher diagnostic yield with fewer needle passes. The aim of this study was to assess the difference in diagnostic yield between FNA and FNB. METHODS: This is a multicenter, prospective randomized clinical trial from six large tertiary care centers. Patients referred for tissue sampling of solid lesions were randomized to either FNA or FNB of the target lesion. Demographics, size, location, number of needle passes, and final diagnosis were recorded. RESULTS: After enrollment, 135 patients were randomized to FNA (49.3%) and 139 patients were randomized to FNB (50.7%).The following lesions were sampled: mass (n=210; 76.6%), lymph nodes (n=46, 16.8%), submucosal tumors (n=18, 6.6%). Final diagnosis was malignancy (n=192, 70.1%), reactive lymphadenopathy (n=30, 11.0%), and spindle cell tumors (n=24, 8.8%). FNA had a diagnostic yield of 91.1% compared to 88.5% for FNB (p=0.48). There was no difference between FNA and FNB when stratified by the presence of on-site cytopathology or by type of lesion sampled A median of 1 needle pass was needed to obtain a diagnostic sample for both needles. CONCLUSION: FNA and FNB obtained a similar diagnostic yield with a comparable number of needle passes. Based on these results, there is no significant difference in the performance of FNA compared to FNB in the cytological diagnosis of solid lesions adjacent to the GI tract. (ClincalTrials.gov identifier: NCT01698190).
PMID: 28624647
ISSN: 1542-7714
CID: 2604112

Split- versus single-dose preparation tolerability in a multiethnic population: decreased side effects but greater social barriers

Perreault, Gabriel; Goodman, Adam; Larion, Sebastian; Sen, Ahana; Quiles, Kirsten; Poles, Michael; Williams, Renee
Background/UNASSIGNED:This study was performed to compare patient-reported tolerability and its barriers in single- vs. split-dose 4-L polyethylene glycol (PEG) bowel preparation for colonoscopy in a large multiethnic, safety-net patient population. Methods/UNASSIGNED:A cross-sectional, dual-center study using a multi-language survey was used to collect patient-reported demographic, medical, socioeconomic, and tolerability data from patients undergoing outpatient colonoscopy. Univariate and multivariate analyses were used to identify demographic and clinical factors significantly associated with patient-reported bowel preparation tolerability. Results/UNASSIGNED:A total of 1023 complete surveys were included, of which 342 (33.4%) completed single-dose and 681 (66.6%) split-dose bowel preparation. Thirty-nine percent of the patients were Hispanic, 50% had Medicaid or no insurance, and 34% had limited English proficiency. Patients who underwent split-dose preparation were significantly more likely to report a tolerable preparation, with less severe symptoms, than were patients who underwent single-dose preparation. Multiple logistic regression revealed that male sex and instructions in the preferred language were associated with tolerability of the single-dose preparation, while male sex and concerns about medications were associated with tolerability of the split-dose preparation. Conclusions/UNASSIGNED:In a large multiethnic safety-net population, split-dose bowel preparation was significantly more tolerable and associated with less severe gastrointestinal symptoms than single-dose preparation. The tolerability of split-dose bowel preparation was associated with social barriers, including concerns about interfering with other medications.
PMCID:5924859
PMID: 29720862
ISSN: 1108-7471
CID: 3061682

Side effects do not influence likelihood to repeat colonoscopy in split versus single dose bowel preparation [Meeting Abstract]

Perreault, G; Larion, S; Sen, A; Poles, M A; Williams, R; Goodman, A
Introduction: Effectiveness of colonoscopy is limited by inadequate bowel preparation. Failure of proper cleansing is multifactorial, but includes the inability of patients to tolerate the bowel preparation due to side effects. It is unknown whether or not the experience with split dose preparation increases adherence to recommendation for repeat colonoscopy. Few studies to date have evaluated potential barriers to bowel preparation in underserved populations. The purpose of this study was to identify whether adverse effects of bowel preparation affect the likelihood of repeating a colonoscopy in a split-dose versus a single dose cohort Methods: Demographic, socioeconomic, medical, education and tolerability data were collected prospectively using a multi-language questionnaire. Descriptive statistics and multivariate analyses were performed on all variables assessed by our questionnaire to evaluate for differences in patients who were likely or unlikely to repeat the preparation. Results: A total of 990 patients satisfied the study criteria (Figure 1). 54.6% of the patients were male, 39.7% Hispanic, 41.2% with less than a high school education, and 38.9% without medical insurance. 336 (34%) completed single dose and 654 (66%) completed split dose colon preparation. In the single dose cohort there were no statistically significant differences in the side effects experienced between patients who would and would not repeat the bowel preparation (Table 1). In contrast, in the split-dose cohorts, complaints of bad taste in mouth, nausea/vomiting and headache were statistically significant causes of a patient being unlikely to repeat the bowel preparation (p < .05) (Table 2). Despite the difference in the role of symptoms in willingness to repeat colon preparation between split dose versus single does preparation groups, there was no significant difference in overall willingness to repeat colon preparation between groups (69.0% versus 71.6%, p = 0.45). Conclusion: This study highlights differences in side effects experienced by patients taking a split dose compared to a single dose preparation. Despite these differences, patients in both groups were likely to repeat a colonoscopy. These results should give a provider confidence in prescribing a split dose preparation to a diverse patient population
EMBASE:620838910
ISSN: 1572-0241
CID: 2968282

Willingness to repeat a colonoscopy preparation in split versus single dose in patients with a high social deprivation index [Meeting Abstract]

Larion, S; Perreault, G; Sen, A; Poles, M A; Goodman, A; Williams, R
Introduction: Efficacy of colonoscopy is limited by inadequate preparation. A high social deprivation index has been identified as a risk factor for failure to repeat a colonoscopy when indicated. It is unknown whether or not split dose preparation increases adherence to recommendation for repeat colonoscopy. Few studies to date have evaluated the potential barriers to likelihood of repeating a bowel preparation in an underserved population. The purpose of this study was to identify factors associated with an increased likelihood of repeating a bowel preparation in a population with a high social deprivation index in a split-dose versus a single dose cohort Methods: Demographic, socioeconomic, medical, education and tolerability data were collected prospectively using a multi-language questionnaire. Descriptive statistics and multivariate analyses were performed on all variables assessed by our questionnaire to evaluate for differences in patients who were likely and unlikely to repeat the preparation. Results: Demographics are presented in table 1 (N=990). 336 (34%) completed single dose and 654 (66%) completed split dose colon preparation. Split dose patients were equally willing-to-repeat colonoscopy preparation compared to single dose patients (69.0% vs. 71.6%; P=0.45) (Table 2). Patients who were not willing to repeat split preparation complained of significantly more adverse gastrointestinal symptoms and difficulty completing dosing instructions due to social barriers and tolerability issues compared to single-dose cohort. Multivariable analysis revealed that concerns with time off work (OR: 0.48; 95% CI: 0.29-0.80), availability of appropriate food/drinks (OR: 0.59; CI: 0.36-0.97), tolerability (OR: 0.72; CI: 0.57-0.92), and colonoscopy scheduling (OR: 0.77; CI: 0.63- 0.94) were all factors independently associated with decreased willingness to repeat in the split dose cohort. Nurse's instruction in preferred language (OR: 2.69; CI: 1.22-5.91) and tolerability (OR: 0.71; CI: 0.55-0.92) were independently associated with patient willingness-to-repeat in the single-dose cohort. Conclusion: This study highlights that tolerability significantly effects repeatability in both single and split dose cohorts. It should be noted that patients with a high social deprivation index identify different barriers to single and split dose preparations. This observation could impact choice of preparation as it affects adherence to physician recommendations. (Figure Presented)
EMBASE:620838817
ISSN: 1572-0241
CID: 2968292

Massive gastrointestinal hemorrhage from aortoesophageal fistula in a patient with congenital double aortic arch [Meeting Abstract]

Pitman, M; Mocharla, R; Villanueva, G; Goodman, A
Double aortic arch is a rare congenital anomaly usually recognized in infancy or childhood. We present an unusual case of massive gastrointestinal hemorrhage resulting from aortoesophageal fistula complicating previously unrecognized double aortic arch in an adult. A 52 year-old man with a prior history of mild intermittent asthma was admitted to the hospital with a severe asthma exacerbation requiring endotracheal intubation. His course was complicated by prolonged respiratory failure and lower extremity deep venous thrombosis. He received enteral feeding via nasogastric tube throughout the period of mechanical ventilation. Several days after initiation of anticoagulation with enoxaparin, he developed melena, hypotension, and acute blood loss anemia. Urgent upper endoscopy revealed an actively bleeding ulcer in the mid esophagus, thought to have been caused by nasogastric tube trauma. Endoscopic hemostasis was achieved with epinephrine injection and clip placement. The patient recovered from this episode and anticoagulation was resumed after 72 hours. Four days later, the patient developed large volume hematemesis and hemodynamic shock requiring massive transfusion. Upper endoscopy revealed active hemorrhage at the same site in the mid esophagus, and hemostasis was again achieved with clip placement. Due to repeat massive esophageal bleeding of uncertain etiology, the patient underwent computed tomography of the chest, which revealed a right-dominant double aortic arch and aortoesophageal fistula. He underwent emergent surgery with ligation of the left-sided arch and repair of the fistula. He recovered from surgery and bleeding has not recurred. Double aortic arch (DAA), or vascular ring, is a rare developmental anomaly which usually presents in infancy or childhood. Aortoesophageal fistula due to a tight vascular ring is exceedingly rare and usually fatal. It has been reported in a handful of cases to have been precipitated by the use of a nasogastric tube. To our knowledge, this is the first case of aortoesophageal complicating DAA in a patient over 40 years old. Due to the high risk of massive hemorrhage and circulatory collapse, this case illustrates that vascular anomalies should be considered in adults with presenting with significant nonvariceal esophageal hemorrhage, prompting early consideration of cross sectional imaging. (Figure Presented)
EMBASE:620839956
ISSN: 1572-0241
CID: 2968122

The Effect of Time to Endoscopy on Patient and Procedural Outcomes Among Foreign Body Swallowers: A Prospective Study [Meeting Abstract]

Ali, Rabia; Sartori, Daniel; Chhabra, Natasha; Minhas, Hadi J; Fang, Yixin; Williams, Renee; Goodman, Adam J
ISI:000403087401190
ISSN: 1097-6779
CID: 2611342

Effect of Race and Gender on Adenoma Detection Rates in a Multi-Racial Immigrant Population [Meeting Abstract]

Williams, Renee; Leung, Galen; Chaudhary, Noami; Ma, Andrew; Goldowsky, Alexander; Cohen, Cynthia; Khan, Abraham; Goodman, Adam J
ORIGINAL:0011918
ISSN: 0016-5085
CID: 2546052

Pathology and Distribution of Colonic Polyps Based on Race and Sex in a Multi-Racial Immigrant Population [Meeting Abstract]

Williams, Renee; Leung, Galen; Chaudhary, Noami; Ma, Andrew; Goldowsky, Alexander; Cohen, Cynthia; Khan, Abraham; Goodman, Adam J
ORIGINAL:0011919
ISSN: 0016-5085
CID: 2546062

Efficacy of Endotherapy in the Treatment of Pain Associated With Chronic Pancreatitis: A Systematic Review and Meta-Analysis

Jafri, Mikram; Sachdev, Amit; Sadiq, Javed; Lee, David; Taur, Ting; Goodman, Adam; Gress, Frank
BACKGROUND: Endotherapy is a treatment modality that can be used to manage the pain associated with chronic pancreatitis. The aim of this systematic review and meta-analysis is to evaluate the efficacy of endotherapy in the management of pain associated with chronic pancreatitis. METHODS: A search of Medline, Pubmed, and Embase databases between 1988 to December 2014 was conducted to evaluate the use of endotherapy for pain relief in patients with chronic pancreatitis. We included large prospective studies, randomized controlled trials and retrospective analyses. Exclusion criteria included studies not written in the English language, small studies with less than 10 patients, case series/case reports and studies that enrolled patients treated with dual therapies including surgery or celiac plexus neurolysis. In addition, a subgroup analysis was conducted to evaluate studies that included patients with pancreatic duct strictures. A meta-analysis was performed and the data on pain relief was subsequently extracted, pooled, and analyzed. I2 index estimates were calculated to test for variability and heterogeneity across the included studies. RESULTS: Our final analysis included sixteen studies, comprising 1498 patients. Eleven studies presented data on immediate pain relief after endotherapy and twelve studies presented data on both immediate and long term pain relief (mean follow up was 47.4 months). The compiled result of the sixteen studies for immediate pain relief demonstrated 88% efficacy (95% NT CI [81.0%, 94%]) of endotherapy. Similarly, analysis of pain relief on long term follow-up showed a 67% efficacy of endotherapy (95% NT CI [58%, 76%]). The compiled complication rate for endotherapy in this review was 7.85% per ERCP/endotherapeutic procedure and the most common complications were acute pancreatitis, stent occlusion and stent migration. CONCLUSIONS: Endotherapy is beneficial for both immediate and long term management of pain associated with chronic pancreatitis. The efficacy of endotherapy decreases over time as assessed by evaluating pain relief on long term follow up. Given the considerable heterogeneity of reported data, additional prospective and standardized multicenter studies need to be conducted to evaluate the efficacy of this modality in controlling pain associated with chronic pancreatitis.
PMCID:5619873
PMID: 28966569
ISSN: 1590-8577
CID: 2719762

Clinical outcomes of EUS-guided drainage of debris-containing pancreatic pseudocysts: a large multicenter study

Yang, Dennis; Amin, Sunil; Gonzalez, Susana; Mullady, Daniel; Edmundowicz, Steven A; DeWitt, John M; Khashab, Mouen A; Wang, Andrew Y; Nagula, Satish; Buscaglia, Jonathan M; Bucobo, Juan Carlos; Wagh, Mihir S; Draganov, Peter V; Stevens, Tyler; Vargo, John J; Khara, Harshit S; Diehl, David L; Keswani, Rajesh N; Komanduri, Srinadh; Yachimski, Patrick S; Prabhu, Anoop; Kwon, Richard S; Watson, Rabindra R; Goodman, Adam J; Benias, Petros; Carr-Locke, David L; DiMaio, Christopher J
Background and study aims Data on clinical outcomes of endoscopic drainage of debris-free pseudocysts (PDF) versus pseudocysts containing solid debris (PSD) are very limited. The aims of this study were to compare treatment outcomes between patients with PDF vs. PSD undergoing endoscopic ultrasound (EUS)-guided drainage via transmural stents. Patients and methods Retrospective review of 142 consecutive patients with pseudocysts who underwent EUS-guided transmural drainage (TM) from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TM technical success, treatment outcomes (symptomatic and radiologic resolution), need for endoscopic re-intervention at follow-up, and adverse events (AEs). Results TM was performed in 90 patients with PDF and 52 with PSD. Technical success: PDF 87 (96.7 %) vs. PSD 51 (98.1 %). There was no difference in the rates for endoscopic re-intervention (5.5 % in PDF vs. 11.5 % in PSD; P = 0.33) or AEs (12.2 % in PDF vs. 19.2 % in PSD; P = 0.33). Median long-term follow-up after stent removal was 297 days (interquartile range [IQR]: 59 - 424 days) for PDF and 326 days (IQR: 180 - 448 days) for PSD (P = 0.88). There was a higher rate of short-term radiologic resolution of PDF (45; 66.2 %) vs. PSD (21; 51.2 %) (OR = 0.30; 95 % CI: 0.13 - 0.72; P = 0.009). There was no difference in long-term symptomatic resolution (PDF: 70.4 % vs. PSD: 66.7 %; P = 0.72) or radiologic resolution (PDF: 68.9 % vs. PSD: 78.6 %; P = 0.72) Conclusions There was no difference in need for endoscopic re-intervention, AEs or long-term treatment outcomes in patients with PDF vs. PSD undergoing EUS-guided drainage with transmural stents. Based on these results, the presence of solid debris in pancreatic fluid collections does not appear to be associated with a poorer outcome.
PMCID:5305425
PMID: 28210709
ISSN: 2364-3722
CID: 2449372