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Comparison of Adenoma Detection Rate by a High Definition Colonoscopy versus Standard High Definition Colonoscopy-A Prospective Randomized Multicenter Trial [Meeting Abstract]

Shirin, Haim; Shpak, Beni; Epshtein, Julia; Vilmann, Peter; Hoffman, Arthur; Ishaq, Sauid; Testoni, Pier Alberto; Sanduleanu, Silvia; Neumann, Helmut; Goetz, Martin; Siersema, Peter D; Gross, Seth A; Abramowich, Dov; Shnell, Mati; Mizrahi, Meir; Hendel, Jakob; Viale, Edi; de Ridder, Rogier; Pochapin, Mark; Yair, Michael; Gluck, Nathan; Yaari, Shaul; Stigaard, Trine; Maliar, Amit; Moshkowitz, Menachem; Israeli, Eran; Matalon, Shai; Hershcovici, Tiberiu; Simantov, Roman; Jacob, Harold; Shachar, Eyal; Karstensen, John G; Teubner, Daniel; Bogie, Roel; Kiesslich, Ralf
ISI:000381906900186
ISSN: 1097-6779
CID: 2481662

A Novel Device for Improving Visualization in an Inadequately Prepared Colon [Meeting Abstract]

Gross, Seth A; Gerson, Lauren B; Lewis, Blair S; Ganz, Robert A
ISI:000381906900427
ISSN: 1097-6779
CID: 2481672

Deep enteroscopy with a conventional colonoscope: initial multicenter study by using a through-the-scope balloon catheter system

Ali, Rabia; Wild, Daniel; Shieh, Frederick; Diehl, David L; Fischer, Monika; Tamura, Wataru; Rubin, David T; Kumbhari, Vivek; Okolo, Patrick; Storm, Andrew; Halpern, Zamir; Neumann, Helmut; Khara, Harshit S; Pochapin, Mark B; Gross, Seth A
BACKGROUND AND AIMS: The advent of capsule endoscopy has revolutionized evaluation of the small bowel. Capsule endoscopy has become the criterion standard as the initial examination to diagnose small-bowel abnormalities, but does not allow for tissue sampling or therapeutic intervention. Deep enteroscopy can be performed by using a balloon-assisted device or a spiral overtube for both diagnostic and therapeutic interventions of the small bowel. Deep enteroscopy is time-consuming and requires special endoscopes and accessories to perform the examination. We studied a novel through-the-scope balloon catheter system used for deep enteroscopy that uses a conventional colonoscope and standard accessories. METHODS: We performed a 9-center, retrospective study using a novel TTS balloon system for small-bowel evaluation. The new through-the-scope device is an on-demand balloon catheter that is inserted through the instrument channel of a standard colonoscope and enables deep advancement into the small bowel in either the anterograde or retrograde approach. It consists of a balloon inflation/deflation system and a single-use balloon catheter designed for anchoring in the small bowel. The balloon is inflated to an anchoring pressure in the small intestine, and a repetitive push-pull technique is performed, with the endoscope sliding over the guiding catheter to the inflated balloon. The catheter may be removed and reinserted to allow for therapeutic intervention while maintaining the endoscope position. RESULTS: A total of 98 patients were included; 52% were male, and the mean age was 55 years old (range 15-94 years). Indications included abdominal pain, iron-deficiency anemia, occult GI bleeding, diarrhea, abnormal capsule endoscopy, weight loss, protein losing enteropathy, retained foreign body, altered anatomy ERCP, and small-bowel strictures. Anterograde enteroscopy was performed in 65 patients. The average depth of insertion was 158 cm (range 50-350 cm) from the pylorus. Retrograde enteroscopy was performed in 33 cases. The average depth of insertion was 89 cm (range 20-150 cm) beyond the ileocecal valve. Overall, diagnostic yield was 44%. The average advancement time for the anterograde and retrograde enteroscopy cases was 15.5 minutes. There were no procedural adverse outcomes reported in the 98 cases. CONCLUSIONS: The TTS advancing balloon is a safe and effective way to perform deep enteroscopy by using a conventional colonoscope without the need for an overtube. Procedure time is shorter than that of other forms of deep enteroscopy. Diagnostic yield and depth of insertion are on par with other forms of deep enteroscopy. This is the largest reported study using this novel technology to diagnose and treat small-bowel disease.
PMID: 26092618
ISSN: 1097-6779
CID: 1631172

Conservative Non-surgical Management of High Risk IPMNs: A Retrospective Chart Review [Meeting Abstract]

Ali, Rabia; Mone, Anjali; Ream, Justin; Megibow, Alec; Pochapin, Mark; Gross, Seth A
ISI:000363715900092
ISSN: 1572-0241
CID: 2538192

Prospective randomized multicenter trial to compare adenoma detection rate of G-eyeTM high definition colonoscopy with standard high definition colonoscopy-initial results [Meeting Abstract]

Mizrahi, M; Shirin, H; Abramowich, D; Stigaard, T; Vilmann, P; Gluck, N; Shnell, M; Ishaq, S; Epshtein, J; Moshkowitz, M; Hoffman, A; Yaari, S; Israeli, E; Hendel, J; Simantov, R; Jacob, H; Brachman, Y; Hershcovici, T; Shpak, B; Tsvang, E; Thielsen, P; Vilkin, A; Rey, J; Neumann, H; Goetz, M; Siersema, P D; Gross, S A; Pochapin, M; Teubner, D; Karstensen, J G; Kiesslich, R
Introduction: The prevention of colorectal cancer (CRC) by colonoscopy is attributed to the identification and removal of adenomas. A significant number of adenomas are missed during Standard Colonoscopy (SC), e.g., due to polyps hidden behind colon folds and flexures. The newly developed G-EYETM Endoscope (SMART Medical Systems Ltd, Ra'anana, Israel) combines a forward viewing endoscope with an integral, reusable balloon at its bending section. During withdrawal of the G-EYETM Endoscope, the balloon is partially inflated, allowing for the flattening of colon folds, centralization of the optical image, and reduction in bowel slippage, thus providing enhanced visualization of the colon and increased detection of polyps and adenomas. Aims & Methods: The aim of this study is to compare the adenoma detection rate (ADR) of G-EYETM high definition (HD) colonoscopy with that of standard HD colonoscopy. From May 2014 to April 2015, patients (age450) referred to colonoscopy for screening, surveillance, following positive fecal occult blood test (FOBT), or due to change of bowel habits, were randomized to either SC group or G-EYETM group. The G-EYETM Endoscope was based on the same instrument as the conventional HD-colonoscope. Results: 360 subjects were enrolled to the study, of which 177 subjects were randomized to the SC group and 183 subjects were randomized to the GEYE TM group. The ADR, adenoma per patient, number of advanced adenomas and large-size adenomas for each group are presented in Table 1. Compared with conventional colonoscopy, G-EYETM colonoscopy increased ADR by 58%. Special attention should be given to 55% and 56% increase in number of advanced adenomas and large-size adenomas, respectively. Procedural times were similar between the two groups. Conclusion: Our study has shown that the G-EYETM endoscope has a substantially higher ADR, compared to SC, which is considered to be one of the indicators for quality in colonoscopy. Moreover, the G-EYETM endoscope is able to detect not only small and diminutive adenomas but also a larger number of advanced and large size adenomas. It is therefore concluded that the GEYETM has the potential to reduce colonoscopic miss rates and reduce interval cancer incidents. (Table Presented)
EMBASE:72267408
ISSN: 2050-6406
CID: 2151302

Increased detection of Barrett's esophagus and esophageal dysplasia using transepithelial brush biopsy with three dimensional computer-assisted tissue analysis: A prospective multi-site communitybased study [Meeting Abstract]

Gross, S A; Smith, M; Ali, R; Kaul, V
Introduction: Barrett's esophagus (BE) is a known precursor to esophageal adenocarcinoma. Endoscopic guidelines for BE and esophageal dysplasia (ED), rely on random four-quadrant forceps biopsies (FB) obtained every 1-2 cm in the BE segment, and are subject to sampling error. Wide area transepithelial brush biopsy combined with 3 dimensional computer image analysis of the sample (WATS3D) previously has been shown to provide incremental value as an adjunct to FB in the detection of both BE and ED. Aims & Methods: A prospective multi-center, community-based trial utilizing WATS3D testing was conducted during the period 2012-2014. Patents with symptoms of reflux, suspected BE, and known BE undergoing surveillance for ED were enrolled. A specially designed transepithelial WATS3D biopsy brushes for tissue sampling in addition to forceps biopsies (FB) during the same endoscopy. WATS3D and FB samples were sent to a central laboratory for analysis. In contrast to the standard 2 micron cut tissue slice, WATS3D biopsy specimens also include an uncut direct smear of up to 150 microns in thickness to better capture the natural three dimensional appearance of the glandular tissue. Laboratory analysis of this uniquely thick tissue sample is aided by a computer based image processing system that integrates into a single three dimensional image information taken from up to 150 separate one micron focal planes. This information is then automatically reviewed by the systems image processing algorithms and neural networks which select and display to the pathologist the most suspicious cells that are found in every focal plane of the entire WATS3D specimen. Results: There were 4203 patients enrolled in the study with adequate FB and WATS3D specimens. The medianage was 59 yr with 43% being males. BE was diagnosed in 594 patients by FB and in 799 patients byWATS3D. Of these 799 patients, 493 had no BE seen on FB. Thus, the addition WATS3D tothe standard forceps biopsy protocol increased the detection of BE by 83.0% (493/594; 95%confidence interval 74%493%), This added detection of BE in 12% (493/ 4203) of all patients testedwith WATS3D results in a number of patients needed to test (NNT) to obtain one additional BEpatient of 8.53. Esophageal dysplasia was diagnosed in 26 patients by FB and in 33 patients byWATS3D. Of these 33 patients, 23 had no ED on FB. Thus, the addition of WATS3D to the standardforceps biopsy protocol increased ED detection by 88.5% (23/26; 95% confidenceinterval 48%4160%). This augmented ED detection in 0.5% (23/4203) of all screening patients testedwith WATS3D, results in an NNT to obtain one additional ED case of 182.7. There were no adverse events which resulted from use of WATS3D. Conclusion: This multi-center trial demonstrates the benefit of WATS3D use in daily community-based endoscopic practice. These results underscore previous data demonstrating the adjunctive benefit of adding WATS3D to FB for augmented detection of both Barrett's metaplasia and dysplasia. (Table Presented)
EMBASE:72265902
ISSN: 2050-6406
CID: 2151322

Inter-Observer Agreement among Pathologists Using Wide-Area Transepithelial Sampling With Computer-Assisted Analysis in Patients With Barrett's Esophagus

Vennalaganti, Prashanth R; Naag Kanakadandi, Vijay; Gross, Seth A; Parasa, Sravanthi; Wang, Kenneth K; Gupta, Neil; Sharma, Prateek
OBJECTIVES: The histopathological diagnosis of Barrett's esophagus (BE)-associated dysplasia has poor inter-observer agreement. The wide-area transepithelial sampling (WATS) procedure uses a minimally invasive brush biopsy technique for acquiring wide-area sampling of BE tissue followed by computer-assisted analysis. In this study, our aim was to assess inter-observer agreement among pathologists in the diagnosis of Barrett's-associated dysplasia using the WATS computer-assisted analysis technique. METHODS: WATS slides with varying degrees of BE dysplasia were randomly selected and distributed to four pathologists. Each pathologist graded the slides as nondysplastic, low-grade dysplasia (LGD), or high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) and completed a standardized case report form (CRF) for each slide. RESULTS: In all, 149 BE slides were evaluated in a blinded manner by 4 pathologists. The slides included the following: no dysplasia (n=109), LGD, and HGD/EAC (n=40). The overall mean kappa value for all 3 diagnoses for the 4 observers was calculated at 0.86 (95% confidence interval (CI) 0.75-0.97). The kappa values (95% CI) for HGD/EAC, IND/LGD, and no dysplasia were 0.95 (0.88-0.99), 0.74 (0.61-0.85), and 0.88 (0.81-0.94), respectively. CONCLUSIONS: The diagnosis of BE and associated dysplasia using the WATS technique has very high inter-observer agreement. This appears to be significantly higher as compared with previously published data using standard histopathology.
PMID: 25916227
ISSN: 1572-0241
CID: 1773022

Balloon-Assisted Colonoscopy Significantly Improves Adenoma Detection Rates - Results of a Multicenter Prospective Cohort Study [Meeting Abstract]

Halpern, Zamir; Gonzalez, Adolfo Suarez; Ishaq, Sauid; Neumann, Helmut; Hoffman, Arthur; Shirin, Haim; Viale, Edi; Hendel, Jakob; Senturk, Hakan; Jacob, Harold; Pochapin, Mark; Gross, Seth A; Kiesslich, Ralf
ISI:000360118800525
ISSN: 1528-0012
CID: 2538182

Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study

Halpern, Zamir; Gross, Seth A; Gralnek, Ian M; Shpak, Beni; Pochapin, Mark; Hoffman, Arthur; Mizrahi, Meir; Rochberger, Yosef S; Moshkowitz, Menachem; Santo, Erwin; Melhem, Alaa; Grinshpon, Roman; Pfefer, Jorge; Kiesslich, Ralf
PMID: 25826167
ISSN: 1438-8812
CID: 1520922

Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study

Halpern, Zamir; Gross, Seth A; Gralnek, Ian M; Shpak, Beni; Pochapin, Mark; Hoffman, Arthur; Mizrahi, Meir; Rochberger, Yosef S; Moshkowitz, Menachem; Santo, Erwin; Melhem, Alaa; Grinshpon, Roman; Pfefer, Jorge; Kiesslich, Ralf
BACKGROUND AND STUDY AIMS: Although colonoscopy is the "gold standard" for colorectal cancer screening, a significant number of adenomas are still missed during standard colonoscopy, often because they are hidden behind colonic folds and flexures. The aim of this study was to assess the ability of a novel balloon colonoscope (G-EYE endoscope; Smart Medical Systems, Ra'anana, Israel) to increase adenoma detection and reduce the miss rate compared with standard colonoscopy. PATIENTS AND METHODS: This was a multicenter, randomized, prospective, controlled study in patients (age >/= 40 years) undergoing colonoscopy for screening or diagnostic work-up (including surveillance). Patients underwent same-day, back-to-back tandem colonoscopy. Patients in Group A underwent standard colonoscopy followed by balloon colonoscopy, and patients in Group B underwent balloon colonoscopy followed by the standard technique. The adenoma detection and miss rates were compared between the two colonoscopy procedures. RESULTS: A total of 126 patients were enrolled and randomized into Group A (n = 60) or Group B (n = 66). The adenoma miss rate of balloon colonoscopy was significantly lower than that of standard colonoscopy (7.5 % vs. 44.7 %; P = 0.0002). The detection of additional adenomas by balloon colonoscopy was significant (81.0 %; P = 0.0002), in particular, the relative amount of adenomas detected in the ascending colon by balloon colonoscopy was 41 % versus 14 % for standard colonoscopy. CONCLUSIONS: A novel balloon colonoscopy technique detected significantly more adenomas than standard colonoscopy, and missed fewer adenomas. Balloon colonoscopy has the potential to increase the effectiveness of colorectal cancer screening and surveillance colonoscopy.
PMID: 25704662
ISSN: 0013-726x
CID: 1474722