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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
2017 Emily Couric Memorial Lecture: Colorectal Cancer: Polyps, Prevention, and Progress
Pochapin, Mark B
Colorectal cancer remains the second-leading cause of cancer death in the United States-but efforts over the past two decades have resulted in tremendous progress in understanding the biology of how this disease develops, increasing screening rates, and decreasing incidence and mortality in those age 50 years and older. The drivers of this movement have been outstanding leadership, innovation, and collaboration. As we move forward to tackle issues such as the increasing incidence of this disease in younger adults, the need to address disparities in care and outcomes, and our shared goal to reach 80% screening rates, it's important to understand and appreciate the story of our past success in order to advance our future efforts.
PMID: 29997398
ISSN: 1572-0241
CID: 3192622
Recommendations for follow up interval after colonoscopy with inadequate bowel preparation: An analysis from the gi quality improvement consortium (GIQuIC) [Meeting Abstract]
Greenwald, D A; Eisen, G; Bernstein, B B; Pochapin, M B; Schmitt, C M; Holub, J L; Lucas, Williams J; Essex, E; Parker, L
Background: Inadequate bowel preparation is estimated to occur in as many as 25% of colonoscopies, and can lead to adverse outcomes including prolonged examination times, missed lesions of up to 42-48% and an increased rate of complications. Adequacy of bowel preparation is recognized as an important metric when assessing quality of colonoscopy. National guidelines state that when bowel preparation for colonoscopy is considered inadequate, repeat examination should occur within one year. Our aim was to evaluate the timing of recommendation for repeat colonoscopy when inadequate bowel prep was reported using GIQuIC, the GI Quality Improvement Consortium, a large, national clinical gastroenterology data registry. Methods: We performed an analysis of all screening and surveillance colonoscopies among adults age 18-89 reported in GIQuIC during the period from 2010-2017. A standardized data collection tool captured information about bowel preparation quality. GIQuIC prospectively collects patient and procedural information on colonoscopies from over 450 sites across the US. We examined data on colonoscopy where bowel preparation was deemed to be inadequate and then evaluated recommendations for interval follow up. Results: A total of 3,773,519 colonoscopies were analyzed for this study, recorded in the registry between 2010-2017. Inadequate bowel preparation was reported in 201,804 (5.3%). Of these, 127,854 were found on examinations where the indication was screening and 74,220 where the indication was surveillance. The recommendation for follow up interval to be less than one year was made in 25.1% when all examinations were assessed. The rate was 25.6% when only looking at screening exams and 24.2% for surveillance exams. (Table 1) When assessed per physician, data was available for 3582 physicians, and mean performance to recommend follow up in less than one year when poor preparation was noted was 34.2%; median performance was 27.3%. When follow up other than within 1 year was recommended, the recommendation was for none (4.9%), 2 years (5.2%), 3 years (26.7%), 5 years (37.9%), 10 years (11.2%), and other (14.2%) (Table 2) Conclusions: The recommendation for repeat screening or surveillance colonoscopy in less than one year when the index colonoscopy has an inadequate bowel prep is a quality measure in gastroenterology. This study, using data from GIQuIC, demonstrates poor compliance with these guideline recommendations. Given the consequences of poor bowel prep in colonoscopy, including possible missed lesions, repeat examination is recommended soon after the initial procedure, and certainly within one year. Adherence to these guidelines as demonstrated here is low, and this suggests the need to understand factors behind this low adherence, as well as increased education and increased adherence to colorectal cancer screening and surveillance guidelines
EMBASE:622899149
ISSN: 1097-6779
CID: 3193372
Adhering to quality metrics in colonoscopy: we can do better [Editorial]
Liang, Peter S; Pochapin, Mark B
PMID: 29454449
ISSN: 1097-6779
CID: 2963172
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
Colonic irrigation as a non-oral, same-day bowel preparation for colonoscopy: Efficacy, safety, and patient satisfaction [Meeting Abstract]
Smukalla, S M; Liang, P S; Khan, A; Hudesman, D P; Rosenberg, J; Esterow, J; Lucak, B; Pochapin, M B
Introduction: Colonoscopy is the most commonly used test for colorectal cancer screening in the US, but patients often find the oral bowel preparation difficult, inconvenient, or intolerable. Suboptimal bowel prep occurs in 20-24% of colonoscopies, leading to inadequate examinations that necessitate additional procedures. Colonic irrigation is an FDA-approved method of colon cleansing using a warm water lavage, but few studies have evaluated it as preparation for colonoscopy. The purpose of this study is to evaluate colonic irrigation as an alternative to oral bowel prep in patients undergoing screening/ surveillance colonoscopy. Methods: We conducted a single-center, single-arm feasibility study using the Hydro-San Plus system. Patients followed a low-residue diet and took 2 doses of polyethylene glycol the day before the procedure. Colonoscopy was performed immediately following colonic irrigation. Boston Bowel Prep Scale (BBPS) and adverse events were recorded. A telephone questionnaire was administered within 7 days of the procedure. Results: Of the 21 patients enrolled, 48% had at a medical risk factor for poor prep (Table 1). Eighteen patients completed irrigation, of whom 12 (67%) had an adequate bowel prep, defined as BBPS>1 in all segments (Table 2). Two irrigations were not completed due to minor adverse events (discomfort from speculum insertion and rectal abrasion) and 1 was aborted for mechanical repair. There were no major adverse events. Patients with no risk factors for poor prep were 4 times more likely to have an adequate prep, although this was not statistically significant (P=0.14). Half of the patients felt that irrigation was easy (47%) and comfortable (53%), while most felt it was tolerable (71%) and convenient (82%). Among participants who had previous a colonoscopy with oral prep, the majority felt that irrigation was easier (85%), more tolerable (77%), and more convenient (85%) than oral prep. 82% of respondents said they would ask for irrigation again and only 12% said they would refuse if it were offered. Conclusion: Colonic irrigation is a safe and moderately efficacious alternative to oral bowel prep for screening/surveillance colonoscopy. A more potent oral pre-prep, especially for patients with risk factors for poor prep, may improve efficacy. Importantly, patient satisfaction with colonic irrigation appears to be higher than with oral bowel prep. (Table Presented)
EMBASE:620839252
ISSN: 1572-0241
CID: 2968232
The American College of Gastroenterology and the 80% by 2018 Colorectal Cancer Initiative: A Multifaceted Approach to Maximize Screening Rates
Karlitz, Jordan J; Oliphant, Anne-Louise B; Greenwald, David A; Pochapin, Mark B
PMID: 28786408
ISSN: 1572-0241
CID: 2664052
Increased Post-procedural Non-Gastrointestinal Adverse Events After Outpatient Colonoscopy in High-Risk Patients
Johnson, David A; Lieberman, David; Inadomi, John M; Ladabaum, Uri; Becker, Richard C; Gross, Seth A; Hood, Kristin L; Kushins, Susan; Pochapin, Mark; Robertson, Douglas J
BACKGROUND & AIMS: The incidence and predictors of non-gastrointestinal (GI) adverse events (AEs) following colonoscopy are not well understood. We studied the effects of anti-thrombotic agents, cardiopulmonary comorbidities, and age on risk of non-GI AEs after colonoscopy. METHODS: We performed a retrospective longitudinal analysis to assess the diagnosis, procedure, and prescription drug codes in a United States commercial claims database (March 2010 - March 2012). Data from patients at increased risk (n=82,025; defined as patients with pulmonary comorbidities or cardiovascular disease requiring anti-thrombotic medications) were compared with data from 398,663 average-risk patients. In a 1:1 matched analysis, 51,932 patients at increased risk, examined by colonoscopy, were compared with 51,932 matched (based on age, sex, and comorbidities) patients at increased risk who did not undergo colonoscopy. We tracked cardiac, pulmonary, and neurovascular events 1-30 days after colonoscopy. RESULTS: Thirty days after outpatient colonoscopy, non-GI AEs were significantly higher in patients taking anti-thrombotic medications (7.3%; odds ratio [OR], 10.75; 95% CI, 10.13-11.42) or those with pulmonary comorbidities (1.8%; OR, 2.44; 95% CI, 2.27-2.62) vs average-risk patients (0.7%), and in patients 60-69 yrs old (OR, 2.21; 95% CI, 2.01-2.42) or 70 yrs or older (OR, 6.45; 95% CI, 5.89-7.06), compared to patients younger than 50 yrs. The 30-day incidence of non-GI AEs in patients at increased risk who underwent colonoscopy was also significantly higher than in matched patients at increased risk who did not undergo colonoscopy, in the anticoagulant group (OR, 2.31; 95% CI, 2.01-2.65) and in the chronic obstructive pulmonary disease group (OR, 1.33; 95% CI, 1.13-1.56). CONCLUSIONS: Increased number of comorbidities and older age (older than 60 years) are associated with increased risk of non-GI AEs after colonoscopy. These findings indicate the importance of determining comorbid risk and evaluating anti-thrombotic management prior to colonoscopy.
PMID: 28017846
ISSN: 1542-7714
CID: 2383482
G-Eyea,, (sic) High-Definition Colonoscopy Increases Adenoma Detection Rate - a Prospective Randomized Multicenter Study of 1000 Patients [Meeting Abstract]
Shirin, Haim; Shpak, Beni; Epshtein, Julia; Vilmann, Peter; Hoffman, Arthur; Sanduleanu, Silvia; Testoni, Pier Alberto; Ishaq, Sauid; Reddy, Duvur N; Gross, Seth A; Siersema, Peter D; Neumann, Helmut; Goetz, Martin; Abramowich, Dov B; Moshkowitz, Menachem; Mizrahi, Meir; Hendel, Jakob; Rey, Johannes W; de Ridder, Rogier; Viale, Edi; Chaudhari, Hrushikesh; Pochapin, Mark B; Yair, Michael; Shnell, Mati; Yaari, Shaul; Stigaard, Trine; Simantov, Roman; Gluck, Nathan; Israeli, Eran; Sloth, Stine; Matalon, Shay; Vilkin, Alexander; Benson, Ariel; Maliar, Amit; Waizbard, Amir; Hershcovici, Tiberiu; Shachar, Eyal; Tsvang, Eduard; Braverman, Michal; Jacob, Harold; Brachman, Yuri; Karstensen, John G; Teubner, Daniel; Bogie, Roel; Kiesslich, Ralf
ISI:000403087401071
ISSN: 1097-6779
CID: 2611332
Assessment of Adenoma Detection Rate Quintiles in a National Benchmarking Registry [Meeting Abstract]
Pike, Irving M; Eisen, Glenn; Greenwald, David A; Pochapin, Mark B; Schmitt, Colleen M; Holub, Jennifer L
ISI:000403087401049
ISSN: 1097-6779
CID: 2611322