Browsing by Author "Rastogi, Amit"

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    Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial
    (Elsevier, 2021-12) Crockett, Seth D.; Khashab, Mouen; Rex, Douglas K.; Grimm, Ian S.; Moyer, Matthew T.; Rastogi, Amit; Mackenzie, Todd A.; Pohl, Heiko; Medicine, School of Medicine
    Background & Aims Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). Methods In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. Results A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). Conclusion The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. ClinicalTrials.gov, Number: NCT01936948.
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    Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial
    (Elsevier, 2019-10) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Wallace, Michael B.; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of Medicine
    Background & aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon.
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    Cost Effectiveness Analysis Evaluating Real-Time Characterization of Diminutive Colorectal Polyp Histology using Narrow Band Imaging (NBI)
    (2020-01) Patel, Swati G.; Scott, Frank I.; Das, Ananya; Rex, Douglas K.; McGill, Sarah; Kaltenbach, Tonya; Ahnen, Dennis J.; Rastogi, Amit; Wani, Sachin; Medicine, School of Medicine
    Background: Endoscopists and new computer-aided programs can achieve performance benchmarks for real-time diagnosis of colorectal polyps using Narrow-Band Imaging (NBI), though do not perform as well as endoscopists with expertise in advanced imaging. Previous cost-effectiveness studies on optical diagnosis have focused on expert performance, potentially over-estimating its benefits. Aim: Determine cost-effectiveness of an NBI ‘characterize, resect and discard (CRD)’ strategy using updated assumptions based on non-expert performance. Methods: Markov model was constructed to compare cost-effectiveness of the CRD strategy, where diminutive polyps characterized as non-adenomas with high confidence are not resected and adenomas are resected and discarded, versus standard of care (SOC) in which all polyps are resected with histologic analysis. Rates related to NBI performance, missed polyps, polyp progression, malignancy, and complications, as well as quality-adjusted life years (QALYs) were derived from the literature. Costs were age and insurer-specific. Mean QALYs and costs were calculated using first order Monte Carlo simulation. Deterministic and probabilistic sensitivity analyses were conducted. Results: The mean QALY estimates were similar for the CRD (8.563, 95% CI: 8.557-8.571) and SOC strategy (8.563, 8.557-8.571), but costs were reduced ($2,693.06 vs. $2,800.27, mean incremental cost savings: $107.21/person). Accounting for colonoscopy rates, the CRD strategy would save $708 million to $1.06 billion annually. The model was sensitive to the incidence of tubular adenomas; the results were otherwise robust in all other one-way and probabilistic analyses. Conclusions: An NBI CRD strategy is cost-effective when compared to the SOC, even when employed by non-experts. The appreciated benefit is primarily due to cost savings of the CRD strategy.
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    Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial
    (Elsevier, 2020-07) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of Medicine
    Background & aims: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. Methods: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. Results: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). Conclusions: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference.
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    A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills (RATES) Study
    (Elsevier, 2017) Wani, Sachin; Keswani, Rajesh; Hall, Matt; Han, Samuel; Ali, Meer Akbar; Brauer, Brian; Carlin, Linda; Chak, Amitabh; Collins, Dan; Cote, Gregory A.; Diehl, David L.; DiMaio, Christopher J.; Dries, Andrew; El-Hajj, Ihab; Ellert, Swan; Fairley, Kimberley; Faulx, Ashley; Fujii-Lau, Larissa; Gaddam, Srinivas; Gan, Seng-Ian; Gaspar, Jonathan P.; Gautamy, Chitiki; Gordon, Stuart; Harris, Cynthia; Hyder, Sarah; Jones, Ross; Kim, Stephen; Komanduri, Srinadh; Law, Ryan; Lee, Linda; Mounzer, Rawad; Mullady, Daniel; Muthusamy, V. Raman; Olyaee, Mojtaba; Pfau, Patrick; Saligram, Shreyas; Piraka, Cyrus; Rastogi, Amit; Rosenkranz, Laura; Rzouq, Fadi; Saxena, Aditi; Shah, Raj J.; Simon, Violette C.; Small, Aaron; Sreenarasimhaiah, Jayaprakash; Walker, Andrew; Wang, Andrew Y.; Watson, Rabindra R.; Wilson, Robert H.; Yachimski, Patrick; Yang, Dennis; Edmundowicz, Steven; Early, Dayna S.; Department of Medicine, IU School of Medicine
    Background and aims Based on the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers. Methods ASGE recognized training programs were invited to participate and AETs were graded on ERCP and EUS exams using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done using a 4-point scoring system and a comprehensive data collection and reporting system was built to create learning curves using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly. Results Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range 155-650) and 350 (125-500). Overall, 3786 exams were graded (EUS:1137; ERCP–biliary 2280, pancreatic 369). Learning curves for individual endpoints, and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS: 82%; ERCP: 60%) and cognitive (EUS: 76%; ERCP: 100%) competence at conclusion of training. Conclusions These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP.
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    Quality Assurance of Computer-Aided Detection and Diagnosis in Colonoscopy
    (Elsevier, 2019) Vinsard, Daniela Guerrero; Mori, Yuichi; Misawa, Masashi; Kudo, Shin-ei; Rastogi, Amit; Bagci, Ulas; Rex, Douglas K.; Wallace, Michael B.; Medicine, School of Medicine
    Recent breakthroughs in artificial intelligence (AI), specifically via its emerging sub-field “Deep Learning,” have direct implications for computer-aided detection and diagnosis (CADe/CADx) for colonoscopy. AI is expected to have at least 2 major roles in colonoscopy practice; polyp detection (CADe) and polyp characterization (CADx). CADe has the potential to decrease polyp miss rate, contributing to improving adenoma detection, whereas CADx can improve the accuracy of colorectal polyp optical diagnosis, leading to reduction of unnecessary polypectomy of non-neoplastic lesions, potential implementation of a resect and discard paradigm, and proper application of advanced resection techniques. A growing number of medical-engineering researchers are developing both, CADe and CADx systems, some of which allow real-time recognition of polyps or in vivo identification of adenomas with over 90% accuracy. However, the quality of the developed AI systems as well as that of the study designs vary significantly, hence raising some concerns regarding the generalization of the proposed AI systems. Initial studies were conducted in an exploratory or retrospective fashion using stored images and likely overestimating the results. These drawbacks potentially hinder smooth implementation of this novel technology into colonoscopy practice. The aim of this article is to review both contributions and limitations in recent machine learning based CADe/CADx colonoscopy studies and propose some principles that should underlie system development and clinical testing.
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    Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial
    (Elsevier, 2023) Rex, Douglas K.; Haber, Gregory B.; Khashab, Mouen; Rastogi, Amit; Hasan, Muhammad K.; DiMaio, Christopher J.; Kumta, Nikhil A.; Nagula, Satish; Gordon, Stuart; Al-Kawas, Firas; Waye, Jerome D.; Razjouyan, Hadie; Dye, Charles E.; Moyer, Matthew T.; Shultz, Jeremiah; Lahr, Rachel E.; Yuen, Poi Yu Sofia; Dixon, Rebekah; Boyd, LaKeisha; Pohl, Heiko; Medicine, School of Medicine
    Background & Aims Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. Methods We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. Results There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. Conclusions In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR.
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    Use of Endoscopic Impression, Artificial Intelligence, and Pathologist Interpretation to Resolve Discrepancies Between Endoscopy and Pathology Analyses of Diminutive Colorectal Polyps
    (Elsevier, 2020-02) Shahidi, Neal; Rex, Douglas K.; Kaltenbach, Tonya; Rastogi, Amit; Ghalehjegh, Sina Hamidi; Byrne, Michael F.; Medicine, School of Medicine