Browsing by Author "Gross, Seth A."

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    Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial
    (Elsevier, 2023-07) Spadaccini, Marco; Hassan, Cesare; Rondonotti, Emanuele; Antonelli, Giulio; Andrisani, Gianluca; Lollo, Gianluca; Auriemma, Francesco; Iacopini, Federico; Facciorusso, Antonio; Maselli, Roberta; Fugazza, Alessandro; Bambina Bergna, Irene Maria; Cereatti, Fabrizio; Mangiavillano, Benedetto; Radaelli, Franco; Di Matteo, Francesco; Gross, Seth A.; Sharma, Prateek; Mori, Yuichi; Bretthauer, Michael; Rex, Douglas K.; Repici, Alessandro; Medicine, School of Medicine
    Background & Aims Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. Methods Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. Results From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00–1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04–1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69–1.14; P = .38). Conclusions The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone.
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    Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection in a Randomized Colonoscopy Trial
    (Elsevier, 2019) Rex, Douglas K.; Slaven, James E.; Garcia, Jonathan; Lahr, Rachel; Searight, Meghan; Gross, Seth A.; Medicine, School of Medicine
    Background & Aims Mucosal exposure devices improve detection of lesions during colonoscopy and have reduced examination times in uncontrolled studies. We performed a randomized trial of Endocuff Vision vs standard colonoscopy to compare differences in withdrawal time (the primary end point). We proposed that Endocuff Vision would allow complete mucosal inspection in a shorter time without impairing lesion detection. Methods Adults older than 40 years undergoing screening or surveillance colonoscopies were randomly assigned to the Endocuff group (n=101, 43.6% women) or the standard colonoscopy group (n=99; 57.6% women). One of 2 experienced endoscopists performed the colonoscopies, aiming for a thorough evaluation of the proximal sides of all haustral folds, flexures, and valves in the shortest time possible. Inspection time was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. Results There were significantly fewer women in the Endocuff arm (P = .0475) but there were no other demographic differences between groups. Mean insertion time with Endocuff was 4.0 min vs 4.4 min for standard colonoscopy (P = .14). Mean inspection time with Endocuff was 6.5 min vs 8.4 min for standard colonoscopy (P < .0001). Numbers of adenomas detected per colonoscopy (1.43 vs 1.07; P = .07), adenoma detection rate (61.4% vs 52%; P = .21), number of sessile serrated polyps per colonoscopy (0.27 vs 0.21; P = .12), and sessile serrated polyp detection rate (19.8% vs 11.1%; P = .09) were all higher with Endocuff Vision. Results did not differ significantly when we controlled for age, sex, or race. Conclusion In a randomized trial, we found inclusion of Endocuff in screening or surveillance colonoscopies to decrease examination time without reducing lesion detection.
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    High-definition colonoscopy versus Endocuff versus EndoRings versus Full-Spectrum Endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial
    (Elsevier, 2018) Rex, Douglas K.; Repici, Alessandro; Gross, Seth A.; Hassan, Cesare; Ponugoti, Prasanna L.; Garcia, Jonathan R.; Broadley, Heather M.; Thygesen, Jack C.; Sullivan, Andrew W.; Tippins, William W.; Main, Samuel A.; Eckert, George J.; Vemulapalli, Krishna C.; Medicine, School of Medicine
    Background Devices used to improve polyp detection during colonoscopy have seldom been compared with each other. Methods We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the Full Spectrum Endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC) Results Among 1,188 patients who completed the study, APC with Endocuff (APC Mean ± SD 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96,) (p<0.001 for APC). Endocuff was higher than standard HD colonoscopy for APC (p=0.014) . Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds) (p=0.006 and 0.018, respectively). Conclusions For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope.
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    Impact of Artificial Intelligence on Colonoscopy Surveillance After Polyp Removal: A Pooled Analysis of Randomized Trials
    (Elsevier, 2023) Mori, Yuichi; Wang, Pu; Løberg, Magnus; Misawa, Masashi; Repici, Alessandro; Spadaccini, Marco; Correale, Loredana; Antonelli, Giulio; Yu, Honggang; Gong, Dexin; Ishiyama, Misaki; Kudo, Shin-ei; Kamba, Shunsuke; Sumiyama, Kazuki; Saito, Yutaka; Nishino, Haruo; Liu, Peixi; Glissen Brown, Jeremy R.; Mansour, Nabil M.; Gross, Seth A.; Kalager, Mette; Bretthauer, Michael; Rex, Douglas K.; Sharma, Prateek; Berzin, Tyler M.; Hassan, Cesare; Medicine, School of Medicine
    Background and aims: Artificial intelligence (AI) tools aimed at improving polyp detection have been shown to increase the adenoma detection rate during colonoscopy. However, it is unknown how increased polyp detection rates by AI affect the burden of patient surveillance after polyp removal. Methods: We conducted a pooled analysis of 9 randomized controlled trials (5 in China, 2 in Italy, 1 in Japan, and 1 in the United States) comparing colonoscopy with or without AI detection aids. The primary outcome was the proportion of patients recommended to undergo intensive surveillance (ie, 3-year interval). We analyzed intervals for AI and non-AI colonoscopies for the U.S. and European recommendations separately. We estimated proportions by calculating relative risks using the Mantel-Haenszel method. Results: A total of 5796 patients (51% male, mean 53 years of age) were included; 2894 underwent AI-assisted colonoscopy and 2902 non-AI colonoscopy. When following U.S. guidelines, the proportion of patients recommended intensive surveillance increased from 8.4% (95% CI, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group (absolute difference, 2.9% [95% CI, 1.4%-4.4%]; risk ratio, 1.35 [95% CI, 1.16-1.57]). When following European guidelines, it increased from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%) (absolute difference, 1.3% [95% CI, 0.01%-2.6%]; risk ratio, 1.22 [95% CI, 1.01-1.47]). Conclusions: The use of AI during colonoscopy increased the proportion of patients requiring intensive colonoscopy surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs.