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Development and validation of the SIMPLE endoscopic classification of diminutive and small colorectal polyps
Iacucci, Marietta; Trovato, Cristina; Daperno, Marco; Akinola, Oluseyi; Greenwald, David; Gross, Seth A; Hoffman, Arthur; Lee, Jeffrey; Lethebe, Brendan C; Lowerison, Mark; Nayor, Jennifer; Neumann, Helmut; Rath, Timo; Sanduleanu, Silvia; Sharma, Prateek; Kiesslich, Ralf; Ghosh, Subrata; Saltzman, John R
BACKGROUND:Prediction of histology of small polyps facilitates colonoscopic treatment. The aims of this study were: 1) to develop a simplified polyp classification, 2) to evaluate its performance in predicting polyp histology, and 3) to evaluate the reproducibility of the classification by trainees using multiplatform endoscopic systems. METHODS:In phase 1, a new simplified endoscopic classification for polyps - Simplified Identification Method for Polyp Labeling during Endoscopy (SIMPLE) - was created, using the new I-SCAN OE system (Pentax, Tokyo, Japan), by eight international experts. In phase 2, the accuracy, level of confidence, and interobserver agreement to predict polyp histology before and after training, and univariable/multivariable analysis of the endoscopic features, were performed. In phase 3, the reproducibility of SIMPLE by trainees using different endoscopy platforms was evaluated. RESULTS: = 0.002). The sensitivity, specificity, positive predictive value, and negative predictive value after training were 97 %, 88 %, 95 %, and 91 %. The interobserver agreement of polyp diagnosis improved from 0.46 (95 %CI 0.30 - 0.64) before to 0.66 (95 %CI 0.48 - 0.82) after training. The trainees demonstrated that the SIMPLE classification is applicable across endoscopy platforms, with similar post-training accuracies for narrow-band imaging NBI classification (0.69; 95 %CI 0.64 - 0.73) and SIMPLE (0.71; 95 %CI 0.67 - 0.75). CONCLUSIONS:Using the I-SCAN OE system, the new SIMPLE classification demonstrated a high degree of accuracy for adenoma diagnosis, meeting the ASGE PIVI recommendations. We demonstrated that SIMPLE may be used with either I-SCAN OE or NBI.
PMID: 29571175
ISSN: 1438-8812
CID: 4903812
Heads or tails: confusion about "proximal" and "distal" terminology for pancreaticobiliary anatomy
Khara, Harshit S; Kothari, Truptesh H; Johal, Amitpal S; Kothari, Shivangi T; Ahuja, Nina; Bhanushali, Ashok; Kotru, Anil; Berger, Andrea; Kaul, Vivek; Gross, Seth A; DiMaio, Christopher J; Hale, William B; Abbass, Rami; Ryou, Marvin; Sethi, Amrita; Turner, Brian G; Fockens, Paul; Diehl, David L
Background and study aims /UNASSIGNED:The anatomical meaning of the terms "proximal" and "distal" in relation to the pancreaticobiliary anatomy can be confusing. We aimed to investigate practice patterns of use of the terms "proximal" and "distal" for pancreaticobiliary anatomy amongst various medical specialties. Materials and methods /UNASSIGNED:An online survey link to a normal pancreaticobiliary diagram was emailed to a multispecialty physician pool. Respondents were asked to label various parts of the common bile duct (CBD) and pancreatic duct (PD) using the terms "proximal," "distal," "not sure," or "other." Variability in use of these terms between specialties was assessed. Results /UNASSIGNED: = 0.1821). Conclusions /UNASSIGNED:Although use of the terms "proximal" and "distal" is still very common to describe pancreaticobiliary anatomy, there is a discordance about its meaning, particularly for the PD. Use of descriptive terminology may be a more accurate alternative to prior ambiguous terminologies such as "proximal" or "distal" and can serve to improve communication and decrease the possibility of medical errors.
PMCID:6031435
PMID: 29977997
ISSN: 2364-3722
CID: 3185902
New technology devices increase sessile serrated adenoma detection rate in colonoscopy - A systematic review and meta-analysis [Meeting Abstract]
Verheyen, E; Castaneda, D; Gross, S A; Popov, V
Background: New technology devices (NTDs) - including Endocuff, Endoring, and Full Spectrum Endoscopy (FUSE) have recently been described as having increased performance in adenoma detection rate as compared to conventional colonoscopy by means of improving colonic mucosal visualization. An increasing awareness of the significant risk of sessile-serrated adenoma progression to malignancy has ushered a need for increased detection of these characteristically flat lesions. Two prior studies evaluating the Endocuff technology and sessile-serrated adenoma detection rate have been published. This is the first meta-analysis comparing the sessile-serrated adenoma detection rate of NTDs and conventional colonoscopy. Methods: Embase and PubMed/MEDLINE databases were searched from inception through November 2017 for published manuscripts or major conference abstracts reporting sessile-serrated adenoma detection rate (SSADR) with Endocuff, EndoRing, G-Eye, FUSE, Third-Eye and conventional colonoscopy. Randomized controlled trials and high-quality case-control studies in adults with >10 subjects were included. Studies excluded were those with overlap in data collection site or time frame. The primary outcome was pooled sessile-serrated adenoma detection rate odds ratio (OR) with 95% confidence interval (95% CI) between conventional colonoscopy and new technology devices. A sub-analysis between Endocuff technology and conventional colonoscopy was performed. Results: Of 163 citations identified, 15 studies with 14,546 subjects were eligible. Four studies were excluded for overlapping collection site or time frame, and two additional studies were excluded for incomplete data reporting within the abstract. A total of nine studies with 5,667 subjects were included in our analysis (2,658 subjects with NTDs and 3,009 with conventional colonoscopy). Seven studies included Endocuff, one with EndoRing, and one with FUSE technology. Mean age was 61.5 (range 59-65), and 60.5% were males. Calculated SSADR with NTDs was 12.6 as compared to 6.5 with conventional colonoscopy, with an increased OR 2.57 (95% CI: 2.09-3.16, p<0.01; I2: 69%)(Figure 1). On Endocuff sub-analysis, seven studies with 4,655 patients were included (2,153 with Endocuff and 2,502 in conventional colonoscopy). Mean age in the sub-analysis was 62.1 (59.8-65), and 62.8% were males. Endocuff sub-analysis of SSADR was 14.0 as compared with 7.3 in conventional colonoscopy, with an increased OR 2.64 (95% CI: 2.12-3.28, p<0.01; I2: 76%). Conclusion: New technology devices, including Endocuff, are an effective option to increase sessileserrated adenoma detection rate. Further studies are needed to evaluate other new technology devices, as well as the long-term impact of increased sessile-serrated adenoma detection rate in colon malignancy. (Table Presented)
EMBASE:622899191
ISSN: 1097-6779
CID: 3193362
High definition-colonoscopy vs. endocuff vs. endorings vs. full-spectrum endoscopy (FUSE) for adenoma detection at colonoscopy: A multicenter randomized trial [Meeting Abstract]
Ponugoti, P L; Rex, D K; Repici, A; Gross, S A; Hassan, C; Eckert, G; Vemulapalli, K
Background and Aim: Colonic mucosal exposure devices such as Endocuff, EndoRings, and Full Spectrum Endoscopy (FUSE) have been investigated in two-arm studies in comparison with standard colonoscopy, but not to each other. We aimed to compare these devices in the hands of colonoscopists with known high adenoma detection rates. Methods: We performed a three center prospective randomized trial. Eligible subjects were 50 years or with indication of screening, surveillance and/or diagnostic and had intact colons. The primary outcome was the rate of conventional adenomas per colonoscopy (APC). Secondary outcomes included the adenoma detection rate (ADR), sessile serrated polyps per colonoscopy (SSPC), the sessile serrated polyp detection rate (SPDR), and colonoscopy insertion times. Results: A total of 1,262 individuals were randomized, of which 1,177 (48.8% female: mean age +/- standard deviation (SD) 62.6 +/- 8.3 years) completed the study. Two hundred and ninety five individuals were randomized to Endocuff; 289 to EndoRings; 298 to FUSE; and 295 to standard HD colonoscopy (control). The overall APC with Endocuff (1.84), EndoRings (1.57), and control (1.53) were all higher than FUSE (1.30) (p=0.001); APC with Endocuff was higher than EndoRings (p=0.048) and control (p=0.004).Right colon APC was higher for Endocuff (p<0.001), EndoRings (p=0.028) and control (p=0.013) compared to FUSE; Endocuff was higher than control (p=0.023). The adenoma detection rate (ADR) was higher with Endocuff, EndoRings and control compared to FUSE; Endocuff was superior to EndoRings (p< 0.001) and control (p<0.004). There was no difference between modalities in detection of conventional adenomas that are 10 mm in size (p=0.537). There were some statistically significant differences between devices in serrated detection but they were small and did not appear clinically significant (Table). The mean cecal insertion times with FUSE (468 sec) and EndoRings (404 sec) were both longer than with Endocuff (354 sec) (p=0.006 and 0.018, respectively). Conclusions: For colonoscopists who are high detectors, 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
EMBASE:622898675
ISSN: 1097-6779
CID: 3193402
Increased detection of Barrett's esophagus and esophageal dysplasia with adjunctive use of wide-area transepithelial sample with three-dimensional computer-assisted analysis (WATS)
Gross, Seth A; Smith, Michael S; Kaul, Vivek
Background/UNASSIGNED:Barrett's esophagus (BE) and esophageal dysplasia (ED) are frequently missed during screening and surveillance esophagoscopy because of sampling error associated with four-quadrant random forceps biopsy (FB). Aim/UNASSIGNED:The aim of this article is to determine if wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS) used adjunctively with FB can increase the detection of BE and ED. Methods/UNASSIGNED:In this multicenter prospective trial, patients screened for suspected BE and those with known BE undergoing surveillance were enrolled. Patients at 25 community-based practices underwent WATS adjunctively to targeted FB and random four-quadrant FB. Results/UNASSIGNED:Of 4203 patients, 594 were diagnosed with BE by FB alone, and 493 additional cases were detected by adding WATS, increasing the overall detection of BE by 83% (493/594, 95% CI 74%-93%). Low-grade dysplasia (LGD) was diagnosed in 26 patients by FB alone, and 23 additional cases were detected by adding WATS, increasing the detection of LGD by 88.5% (23/26, 95% CI 48%-160%). Conclusions/UNASSIGNED:Adjunctive use of WATS to FB significantly improves the detection of both BE and ED. Sampling error, an inherent limitation associated with screening and surveillance, can be improved with WATS allowing better informed decisions to be made about the management and subsequent treatment of these patients.
PMCID:5987273
PMID: 29881608
ISSN: 2050-6406
CID: 3144142
Evaluation of Dysplasia in Barrett Esophagus
Gross, Seth A; Kingsbery, Joseph; Jang, Janice; Lee, Michelle; Khan, Abraham
Barrett esophagus (BE) is the precursor lesion to adenocarcinoma of the esophagus. The current surveillance strategy of 4-quadrant Seattle protocol biopsies has been associated with sampling error and missing higher-risk lesions, and there is often less adherence to endoscopic surveillance with long segments. Advancements in endoscopic imaging and sampling techniques allow for better surveillance of BE, particularly when assessing for dysplasia. This article highlights the key endoscopic imaging and sampling advancements in the evaluation of dysplasia in BE.
PMCID:6009185
PMID: 29942221
ISSN: 1554-7914
CID: 3162502
A novel device for improving visualization in an inadequately prepared colon
Gross, Seth; Gerson, Lauren; Lewis, Blair; Ganz, Robert
BACKGROUND AND AIMS: Adequate bowel preparation is essential for a quality colonoscopy. Poor bowel preparation can result in longer procedural times, missed adenomas, earlier repeat procedures, increase costs, and decreased patient satisfaction [1-5]. Pure-Vu (MOTUS GI, Tirat Carmel, Israel) is a system that facilitates intra-procedural cleaning of a poorly prepared colon during a colonoscopy by irrigating the colon and evacuating the fluid and feces. The study aims were to evaluate Pure-Vu's cleansing capabilities and its usability and safety, in a live animal colon METHODS: The Pure-Vu system was used by four experienced gastroenterologists in 35 Yorkshire cross swine (66% female) that received a reduced bowel preparation to ensure an inadequate bowel preparation at baseline. Before the colonoscopy the Pure-Vu was attached to the colonoscope and the baseline prep was assessed during insertion. The Pure-Vu system was then used to cleanse the colon and the prep was then assessed post-Pure-Vu use. RESULTS: No adverse effects and no failed or prematurely terminated cases were noted. Fourteen percent of the swine colons were adequately prepped at baseline (median BBPS score = 0 [25 percentile=0, 75 percentile =1 ;IQR=1]) and improved to 100% after use of Pure-Vu (Wilcoxon signed rank test p <0.001) (median BBPS score = 3 [25 percentile=3, 75 percentile =3 ;IQR=0]). The physicians found Pure-Vu easy and intuitive to operate. DISCUSSION: The Pure-Vu system effectively cleaned inadequately prepped swine colons and proved to be easy to use. The Pure-Vu device, applied in clinical practice, may result in improved overall prep quality and a reduction in repeat examinations due to inadequately prepped colons.
PMID: 29108983
ISSN: 1097-6779
CID: 2773172
Increased Detection of Barrett's Esophagus-associated Neoplasia Using Wide-Area Trans-epithelial Sampling: A Multicenter, Prospective, Randomized Trial
Vennalaganti, Prashanth R; Kaul, Vivek; Wang, Kenneth K; Falk, Gary W; Shaheen, Nicholas J; Infantolino, Anthony; Johnson, David A; Eisen, Glenn; Gerson, Lauren B; Smith, Michael S; Iyer, Prasad G; Lightdale, Charles J; Schnoll-Sussman, Felice; Gupta, Neil; Gross, Seth A; Abrams, Julian; Haber, Gregory B; Chuttani, Ram; Pleskow, Douglas K; Kothari, Shivangi; Goldblum, John R; Zhang, Yaxia; Sharma, Prateek
BACKGROUND AND AIMS: Wide-area transepithelial sampling (WATS) with computer-assisted 3-dimensional analysis is a sampling technique that combines abrasive brushing of the Barrett's esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells. METHODS: We performed a randomized trial of referral BE patients undergoing surveillance at 16 medical centers. Subjects received either biopsy followed by WATS, or vice versa. The primary outcome was rate of detection of HGD/EAC using WATS in conjunction with biopsy compared with biopsy alone using standard histopathologic criteria. Secondary aims included evaluating neoplasia detection rates (1) based on the procedure order (WATS vs biopsy first) (2) of each procedure separately, and (3) the additional time required for WATS. RESULTS: One hundred sixty patients (mean age 63.4 years, 76% male; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 (IQR: 0.0-5.0) cm and 4.0 (IQR, 2.0-8.0) cm, respectively. The diagnostic yield for biopsy alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); non-dysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% CI, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy as NDBE, and 12 as LGD/IND; 14 received biopsy and 9 WATS first (p=NS) and the majority (n=21; 91.7%) had a prior dysplasia history. WATS added average of 4.5 minutes to the procedure. CONCLUSION: Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC.
PMID: 28757316
ISSN: 1097-6779
CID: 2655502
To cuff or not to cuff: that is the question!
Mahadev, Srihari; Gross, Seth A
PMID: 29073693
ISSN: 1438-8812
CID: 2756492
Improved detection of right-sided adenomas by g-eye colonoscopy in patients undergoing colorectal cancer screening-a prospective, randomized, multicentre study [Meeting Abstract]
Shirin, H; Shpak, B; Epshtein, J; Vilmann, P; Hoffman, A; Sanduleanu, S; Testoni, P A; Ishaq, S; Reddy, D N; Gross, S A; Siersema, P D; Neumann, H; Goetz, M; Abramowich, D; Moshkowitz, M; Mizrahi, M; Hendel, J; Rey, J W; De, Ridder R; Viale, E; Chaudhari, H; Pochapin, M B; Yair, M; Shnell, M; Yaari, S; Stigaard, T; Simantov, R; Gluck, N; Israeli, E; Sloth, S; Matalon, S; Vilkin, A; Benson, A; Maliar, A; Waizbard, A; Hershcovici, T; Shachar, E; Rochberger, S; Tsvang, E; Braverman, M; Jacob, H; Brachman, Y; Karstensen, J G; Teubner, D; Bogie, R; Kiesslich, R
Introduction: Colorectal Cancer (CRC) prevention has resulted in the implementation of screening programs worldwide in hopes to reduce the number of CRC incidences. Despite these programs' best efforts, interval cancers continue to arise from lesions missed during standard procedures. Interval cancers have been found to occur more frequently in the right colon, often developing from flat and sessile lesions. These lesions have had reported miss rates of up to 60% compared to reported miss rates of 20%-30% for polyps and adenomas. The innovative G-EYE endoscope (SMART Medical Systems Ltd, Ra'anana, Israel) includes an integral, reusable balloon that is permanently installed on the distal end of a standard endoscope. Upon withdrawal, inflation of the GEYE balloon to a partial pressure results in the centralization of endoscope optics, reduction in bowel slippage, and flattening of colon topography. The enhanced visualization provided by the G-EYE balloon can result in an increase detection of lesions. Aims & Methods: In this prospective, randomized, multicentre study, patients (age >50) referred to colonoscopy as a result of screening, surveillance, positive FOBT or change in bowel habits were randomized to either standard colonoscopy (SC) or G-EYE colonoscopy. Detected lesions were removed and sent for pathology. We compared the detection rates of G-EYE colonoscopy with that of SC in the right colon. Results: 1000 patients were enrolled in the study, of which 498 underwent SC and 502 underwent G-EYE colonoscopy. Baseline parameters were similar in both groups. The right colon was defined as the cecum, ascending colon, and hepatic flexure. Results are presented in Table 1. In addition, the G-EYEincreased the detection of both advanced and large-size adenomas by 40% in the right colon Conclusion: Our study shows that G-EYE colonoscopy has the potential to significantly improve the quality of CRC screening through improved adenoma detection rates. Special attention should be given to the significant increase in right-sided flat lesions and sessile serrated adenomas by the G-EYE, as these lesions are strongly attributed to CRC. Through increased detection of these right-sided lesions, G-EYE colonoscopy can impact the quality of CRC screening by reducing miss rates and consequently reduce the incidents of interval cancers. (Table Presented)
EMBASE:619890983
ISSN: 2050-6414
CID: 2891942