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EVALUATION OF BOWEL CLEANSING EFFICACY IN HOSPITALIZED PATIENT POPULATION USING THE PURE-VU SYSTEM [Meeting Abstract]

Neumann, H; Latorre, M; Zimmermann, T; Lang, G; Samarasena, J B; Gross, S A; Brahmbhatt, B; Pazwash, H; Kushnir, V
Background: Good colon preparation is critical for ensuring high quality optical colonoscopy (OC). Hospitalized patients are at high risk for inadequate colon preparation for OC due to comorbidities, medication use and debilitated status. Inadequate colon preparation leads to delayed, aborted and rescheduled procedures resulting in prolonged hospitalizations and increased costs. The Pure Vu System is a novel device intended to fit over existing colonoscopes to facilitate intraprocedural cleansing of the colon by simultaneously irrigating and evacuating bowel content.
Method(s): This multicenter, prospective, single-arm study (sponsored by Motus GI)anticipates enrolling up to 100 hospitalized patients to evaluate the Pure-Vu System following standard bowel preparation. This interim analysis summarizes the results of the initial 45 patients enrolled. Upon consenting, patients were consecutively enrolled regardless of the bowel preparation condition and the procedure was performed with the Pure-Vu System. The primary endpoint was improvement of colon cleansing from baseline to post procedure as assessed by the improvement in Boston Bowel Preparation Scale (BBPS)following cleansing with Pure-Vu System Secondary endpoints were rate of patients with successful colonoscopy for the intended indication in the first attempt and safety.
Result(s): Forty-five hospitalized patients (62% males), mean age 63.1 years and mean BMI of 27.1 kg/m2 were included in the analysis. The predominate indication for OC was GI bleeding (62%)(Table 1). In 36 (80%)patients, the physician was able to successfully diagnose in the first attempt per the patients' indication. In these patients, adequate bowel cleansing (BBPS>=2 in each segment that were visualized)was improved from 39% at baseline to 100% after cleansing with the Pure-Vu System. There was one procedure related perforation which required surgical repair, the patient was discharged 48 hours post operatively and fully recovered.
Conclusion(s): Bowel preparation for hospitalized patients remain a significant challenge resulting in delayed/cancelled procedures, missed pathology and increased costs of care. Although a small subset, this first U.S. multicenter study investigates a population that poses the most challenging medical circumstances. One of the limitations of this study is unavailability of the Pure-Vu system compatible with Slim (pediatric)colonoscopes; in 4 of the 9 cases where a conclusive diagnosis could not be obtained, a Slim scope was used to complete the procedure. The Pure-Vu system cleanses the colon intraprocedurally and may improve the efficacy and prevent a delayed or repeat OC procedure. This preliminary analysis demonstrates an increase in the BBPS score following the use of the Pure-Vu System, but more importantly, it demonstrates an increase in colon cleansing adequacy to reach successful diagnosis. [Figure presented][Figure presented]
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EMBASE:2002058916
ISSN: 1097-6779
CID: 3932922

Wide-area transepithelial sampling with computer-assisted 3-dimensional analysis (WATS) markedly improves detection of esophageal dysplasia and Barrett's esophagus: analysis from a prospective multicenter community-based study

Smith, M S; Ikonomi, E; Bhuta, R; Iorio, N; Kataria, R D; Kaul, V; Gross, S A
The 4-quadrant forceps biopsy (FB) protocol for identifying Barrett's esophagus (BE) and esophageal dysplasia (ED) suffers from poor sensitivity due to significant sampling error. We investigated the benefit of wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS) used adjunctively to the combination of random and targeted FB in the detection of ED, and as a secondary outcome, BE. In this multicenter prospective trial, community endoscopists at 21 sites utilized WATS as an adjunct to both targeted and random FB in patients undergoing BE screening and surveillance. Investigators alternated taking FB and WATS samples first. WATS specimens were analyzed at CDx Diagnostics (Suffern, NY) while FB samples were analyzed by each site's regular pathologists. Data were de-identified and then aggregated for analysis. Of 12,899 patients enrolled, FB identified 88 cases of ED, and WATS detected an additional 213 cases missed by FB. These 213 cases represented an absolute increase of 1.65%, raising the yield from 0.68% to 2.33%. Adding WATS to FB increased the overall detection of ED by 242% (95% CI: 191%-315%). Fewer than 61 patients needed to be tested with WATS to identify an additional case of ED. The combination of random and targeted FB identified 1,684 cases of BE, and WATS detected an additional 2,570 BE cases. The absolute incremental yield of adding WATS to FB is 19.9%, increasing the rate of detection from 13.1% to 33%. Adding WATS to FB increased the overall detection of BE by 153% (95% CI: 144-162%). The number needed to test with WATS in order to detect an additional case of BE was 5. Whether FB or WATS was done first did not impact the results. In this study, comprised of the largest series of patients evaluated with WATS, adjunctive use of the technique with targeted and random FB markedly improved the detection of both ED and BE. These results underscore the shortcomings of FB in detecting BE-associated neoplasia, which can potentially impact the management and clinical outcomes of these patients.
PMID: 30541019
ISSN: 1442-2050
CID: 3751972

G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)

Shirin, Haim; Shpak, Beni; Epshtein, Julia; Karstensen, John Gásdal; Hoffman, Arthur; de Ridder, Rogier; Testoni, Pier Alberto; Ishaq, Sauid; Reddy, D Nageshwar; Gross, Seth A; Neumann, Helmut; Goetz, Martin; Abramowich, Dov; Moshkowitz, Menachem; Mizrahi, Meir; Vilmann, Peter; Rey, Johannes Wilhelm; Sanduleanu-Dascalescu, Silvia; Viale, Edi; Chaudhari, Hrushikesh; Pochapin, Mark B; Yair, Michael; Shnell, Mati; Yaari, Shaul; Hendel, Jakob Westergren; Teubner, Daniel; Bogie, Roel M M; Notaristefano, Chiara; Simantov, Roman; Gluck, Nathan; Israeli, Eran; Stigaard, Trine; Matalon, Shay; Vilkin, Alexander; Benson, Ariel; Sloth, Stine; Maliar, Amit; Waizbard, Amir; Jacob, Harold; Thielsen, Peter; Shachar, Eyal; Rochberger, Shmuel; Hershcovici, Tiberiu; Plougmann, Julie Isabelle; Braverman, Michal; Tsvang, Eduard; Abedi, Armita Armina; Brachman, Yuri; Siersema, Peter D; Kiesslich, Ralf
BACKGROUND:Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy (SC) still occur. Increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device comprises a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing ADR. METHODS:In this randomized, controlled, international, multicenter study (11 centers), subjects (age ≥50) referred to colonoscopy for screening, surveillance, or due to changes in bowel habits, were randomized to undergo either balloon-assisted colonoscopy using an insufflated balloon during withdrawal or standard high-definition colonoscopy. Primary endpoint was ADR. RESULTS:One thousand subjects were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (SC: n=396; balloon-assisted colonoscopy: n=407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the SC group (28% increase, p=0.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (p=0.0033), flat adenomas (p<0.0001), and sessile serrated adenoma/polyp (SSA/Ps) (p=0.0026). CONCLUSIONS:Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat and SSA/Ps when compared with SC. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates, and consequently reducing of interval cancers incidence; clinicaltrials.gov (NCT01917513).
PMID: 30273591
ISSN: 1097-6779
CID: 3329152

Predictors of Hospital Readmission Among Patients With Obscure Gastrointestinal Bleeding Following Inpatient Capsule Endoscopy [Meeting Abstract]

Levine, Irving; Hong, Soonwook; Bhakta, Dimpal; McNeill, Matthew B.; Gross, Seth; Latorre, Melissa
ISI:000509756002395
ISSN: 0002-9270
CID: 5524182

DIAGNOSTIC YIELD OF INPATIENT CAPSULE ENDOSCOPY [Meeting Abstract]

Levine, Irving; Bhakta, Dimpal; McNeill, Matthew B.; Gross, Seth A.; Latorre, Melissa
ISI:000470094901295
ISSN: 0016-5107
CID: 5524162

Recent advances in Barrett's esophagus

Inadomi, John; Alastal, Hani; Bonavina, Luigi; Gross, Seth; Hunt, Richard H; Mashimo, Hiroshi; di Pietro, Massimiliano; Rhee, Horace; Shah, Marmy; Tolone, Salvatore; Wang, David H; Xie, Shao-Hua
Barrett's esophagus (BE) is the only known precursor of esophageal adenocarcinoma, one of the few cancers with increasing incidence in developed countries. The pathogenesis of BE is unclear with regard to either the cellular origin of this metaplastic epithelium or the manner in which malignant transformation occurs, although recent data indicate a possible junctional origin of stem cells for BE. Treatment of BE may be achieved using endoscopic eradication therapy; however, there is a lack of discriminatory tools to identify individuals at sufficient risk for cancer development in whom intervention is warranted. Reduction in gastroesophageal reflux of gastric contents including acid is mandatory to achieve remission from BE after endoscopic ablation, and can be achieved using medical or nonmedical interventions. Research topics of greatest interest include the mechanism of BE development and transformation to cancer, risk stratification methods to identify individuals who may benefit from ablation of BE, optimization of eradication therapy, and surveillance methods to ensure that remission is maintained after eradication is achieved.
PMID: 29974975
ISSN: 1749-6632
CID: 3239142

Novel device for measuring polyp size: an ex vivo animal study

Goldstein, Omer; Segol, Ori; Siersema, Peter D; Jacob, Harold; Gross, Seth A
PMID: 28935676
ISSN: 1468-3288
CID: 2708612

Advances in Barrett's Esophagus

Wong, Alina; Gross, Seth A.
Esophageal adenocarcinoma is increasing in frequency in the United States. Barrett's esophagus is the strongest risk factor for esophageal adenocarcinoma making evaluation for Barrett's esophagus of utmost importance. Currently screening and surveillance are accomplished with regular white light endoscopy; however, new advances in both population screening and surveillance are being developed. This review will cover selecting the appropriate patient population for Barrett's esophagus screening, available and upcoming technologies for screening and surveillance, and lastly treatment of Barrett's esophagus.
SCOPUS:85073389861
ISSN: 0277-4208
CID: 4164352

Response [Letter]

Castaneda, Daniel; Gross, Seth A
PMID: 30115316
ISSN: 1097-6779
CID: 3241062

Correction: Development and validation of the SIMPLE endoscopic classification of diminutive and small colorectal polyps [Correction]

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
PMID: 29665615
ISSN: 1438-8812
CID: 3043072