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Colorectal cancer prevention by a CLEAR principles–based colonoscopy protocol: an observational study

Published:December 06, 2019DOI:https://doi.org/10.1016/j.gie.2019.11.043

      Background and Aims

      Colorectal cancer (CRC) prevention by colonoscopy has been lower than expected. We studied CRC prevention outcomes of a colonoscopy protocol based on Clean the colon, Look Everywhere, and complete Abnormality Removal (CLEAR) principles.

      Methods

      This observational follow-up study studied patients provided screening colonoscopy at a free-standing private ambulatory surgery center in South Carolina by 80 endoscopists from October 2001 to December 2014, followed through December 2015. The colonoscopy protocol, optimized for polyp clearance, featured in-person bowel preparation instructions reinforced by phone, polyp search and removal throughout insertion and gradual withdrawal with circumferential tip movements, and a team approach using all personnel present to maximize polyp detection, patient safety, and clear-margin polypectomy including requesting repeat inspection or additional tissue removal. Outcome measures were postscreening lifetime CRC risk relative to Surveillance Epidemiology and End Results (SEER)-18 and interval cancer rate (postcolonoscopy CRCs among cancer-free patients at screening).

      Results

      Of 25,862 patients (mean age, 58.1 years; 52% black; 205,522 person-years of observation), 159 had CRC at screening and 67 patients developed interval CRC. The interval CRC rate was 3.34 per 10,000 person-years of observation, 5.79 and 2.24 among patients with and without adenomas, respectively. The rate was similar among older patients (mean age 68.5 years at screening) and with prolonged follow-up. Postscreening lifetime CRC risk was 1.6% (bootstrap 95% confidence interval, 1.3%-1.8%) versus 4.7% in SEER-18, 67% lower. Subgroups with mean screening ages of 50 and 68.5 years showed risk reductions of 80% and 72%, respectively. The adverse event rate was less than usually reported rates: perforation 2.6 per 10,000, bleeding with hospitalization 2.4 per 10,000, and no deaths.

      Conclusions

      A colonoscopy protocol optimized for polyp clearance prevented 67% of CRC compared with a SEER-18 population given ongoing population screening.

      Graphical abstract

      Abbreviations:

      ADR (adenoma detection rate), CI (confidence interval), CLEAR (Clean the colon, Look Everywhere, complete Abnormality Removal), CRC (colorectal cancer), PYO (person-years of observation), SCCCR (South Carolina Central Cancer Registry), SEER (Surveillance Epidemiology and End Results)
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      References

        • Siegel R.L.
        • Miller K.D.
        • Fedewa S.A.
        • et al.
        Colorectal cancer statistics, 2017.
        CA Cancer J Clin. 2017; 67: 177-193
        • Brenner H.
        • Kretschmann J.
        • Stock C.
        • et al.
        Expected long-term impact of screening endoscopy on colorectal cancer incidence: a modelling study.
        Oncotarget. 2016; 7: 48168-48179
        • Winawer S.J.
        • Zauber A.G.
        • Ho M.N.
        • et al.
        Prevention of colorectal cancer by colonoscopic polypectomy.
        N Engl J Med. 1993; 329: 1977-1981
        • Schatzkin A.
        • Lanza E.
        • Corle D.
        • et al.
        Lack of effect of a low-fat, high-fiber diet on the recurrence of colorectal adenomas.
        N Engl J Med. 2000; 342: 1149-1155
        • Schatzkin A.
        • Lanza E.
        • Freedman L.S.
        • et al.
        The polyp prevention trial I: rationale, design, recruitment, and baseline participant characteristics.
        Cancer Epidemiol Prevent Biomark. 1996; 5: 375-383
        • Click B.
        • Pinsky P.F.
        • Hickey T.
        • et al.
        Association of colonoscopy adenoma findings with long-term colorectal cancer incidence.
        JAMA. 2018; 319: 2021-2031
        • Parker S.L.
        • Tong T.
        • Bolden S.
        • et al.
        Cancer statistics, 1997.
        CA Cancer J Clin. 1997; 47: 5-27
      1. Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, et al. Evaluating test strategies for colorectal cancer screening—age to begin, age to stop, and timing of screening intervals. Evidence Synthesis, No. 65.2 2009 Report No: 08-05124-EF-2. Rockville, MD: Agency for Healthcare Research and Quality, 2009.

        • Meester R.G.
        • Peterse E.F.
        • Knudsen A.B.
        • et al.
        Optimizing colorectal cancer screening by race and sex: microsimulation analysis II to inform the American Cancer Society colorectal cancer screening guideline.
        Cancer. 2018; 124: 2974-2985
        • Ladabaum U.M.A.
        • Meester R.G.S.
        • Gupta S.
        • et al.
        Cost-effectiveness and national effects of initiating colorectal cancer screening for average-risk persons at age 45 years instead of 50 years.
        Gastroenterology. 2019; (157:137-48)
        • Leung K.
        • Pinsky P.
        • Laiyemo A.O.
        • et al.
        Ongoing colorectal cancer risk despite surveillance colonoscopy: the Polyp Prevention Trial Continued Follow-up Study.
        Gastrointest Endosc. 2010; 71: 111-117
        • Nishihara R.
        • Wu K.
        • Lochhead P.
        • et al.
        Long-term colorectal-cancer incidence and mortality after lower endoscopy.
        N Engl J Med. 2013; 369: 1095-1105
        • de Groen P.C.
        Advanced systems to assess colonoscopy.
        Gastrointest Endosc Clin. 2010; 20: 699-716
        • Rex D.K.
        • Cutler C.S.
        • Lemmel G.T.
        • et al.
        Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies.
        Gastroenterology. 1997; 112: 24-28
        • Van Rijn J.C.
        • Reitsma J.B.
        • Stoker J.
        • et al.
        Polyp miss rate determined by tandem colonoscopy: a systematic review.
        Am J Gastroenterol. 2006; 101: 343
        • Duloy A.M.
        • Kaltenbach T.R.
        • Keswani R.N.
        Assessing colon polypectomy competency and its association with established quality metrics.
        Gastrointest Endosc. 2018; 87: 635-644
        • Ferlitsch M.
        • Moss A.
        • Hassan C.
        • et al.
        Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.
        Endoscopy. 2017; 49: 270-297
        • Pohl H.S.A.
        • Bensen S.P.
        • Anderson P.
        • et al.
        Incomplete polyp resection during colonoscopy—results of the Complete Adenoma Resection (CARE) study.
        Gastroenterology. 2013; 144: 74-80
        • Moss A.N.K.
        Standardisation of polypectomy technique.
        Best Pract Res Clin Gastroenterol. 2017; 31: 447-453
        • Barclay R.L.
        • Vicari J.J.
        • Greenlaw R.L.
        Effect of a time-dependent colonoscopic withdrawal protocol on adenoma detection during screening colonoscopy.
        Clin Gastroenterol Hepatol. 2008; 6: 1091-1098
        • Gupta S.
        • Anderson J.
        • Bhandari P.
        • et al.
        Development and validation of a novel method for assessing competency in polypectomy: direct observation of polypectomy skills.
        Gastrointest Endosc. 2011; 73: 1232-1239
        • Patel K.
        • Faiz O.
        • Rutter M.
        • et al.
        The impact of the introduction of formalised polypectomy assessment on training in the UK.
        Frontline Gastroenterol. 2017; 8: 104-109
        • Walsh C.M.
        • Ling S.C.
        • Khanna N.
        • et al.
        Gastrointestinal endoscopy competency assessment tool: development of a procedure-specific assessment tool for colonoscopy.
        Gastrointest Endosc. 2014; 79: 798-807
        • Barton J.R.
        • Corbett S.
        • van der Vleuten C.P.
        • et al.
        The validity and reliability of a direct observation of procedural skills assessment tool: assessing colonoscopic skills of senior endoscopists.
        Gastrointest Endosc. 2012; 75: 591-597
        • Xirasagar S.
        • Li Y.J.
        • Hurley T.G.
        • et al.
        Colorectal cancer prevention by an optimized colonoscopy protocol in routine practice.
        Int J Cancer. 2015; 136: E731-E742
        • North American Association of Central Cancer Registries
        NAACCR certification by registry and year, and certification criteria.
        (Available at:)
        • Rex D.K.
        Colonoscopic withdrawal technique is associated with adenoma miss rates.
        Gastrointest Endosc. 2000; 51: 33-36
        • Xirasagar S.
        • Hurley T.G.
        • Sros L.
        • et al.
        Quality and safety of screening colonoscopies performed by primary care physicians with standby specialist support.
        Med Care. 2010; 48: 703
        • Levin B.
        • Lieberman D.A.
        • McFarland B.
        • et al.
        Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology.
        CA Cancer J Clin. 2008; 58: 130-160
        • Loeve A.J.
        • Fockens P.
        • Breedveld P.
        Mechanical analysis of insertion problems and pain during colonoscopy: why highly skill-dependent colonoscopy routines are necessary in the first place... and how they may be avoided.
        Can J Gastroenterol Hepatol. 2013; 27: 293-302
        • Anderson J.
        Colonoscopy: Do operator motions and posture count?.
        Endosc Int Open. 2015; 3: E627-E628
        • Aslanian H.R.
        • Shieh F.K.
        • Chan F.W.
        • et al.
        Nurse observation during colonoscopy increases polyp detection: a randomized prospective study.
        Am J Gastroenterol. 2013; 108: 166
        • Liker J.K.
        The 14 principles of the Toyota way: an executive summary of the culture behind TPS.
        Toyota Way. 2004; 14: 35-41
        • Johnson D.A.
        • Barkun A.N.
        • Cohen L.B.
        • et al.
        Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US Multi-Society Task Force on colorectal cancer.
        Am J Gastroenterol. 2014; 109: 1528
        • Corley D.A.
        • Jensen C.D.
        • Marks A.R.
        • et al.
        Adenoma detection rate and risk of colorectal cancer and death.
        N Engl J Med. 2014; 370: 1298-1306
        • Zauber A.G.
        • Winawer S.J.
        • O'brien M.J.
        • et al.
        Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths.
        N Engl J Med. 2012; 366: 687-696
        • Rutter M.D.
        • Beintaris I.
        • Valori R.
        • et al.
        World Endoscopy Organization consensus statements on post-colonoscopy and post-imaging colorectal cancer.
        Gastroenterology. 2018; (155:909-25.e3)
        • Fay M.P.
        Estimating age conditional probability of developing disease from surveillance data.
        Popul Health Metrics. 2004; 2: 6
        • SEER. Surveillance research program
        SEER cancer statistics review 1975-2009: Table 6.17: lifetime risk of being diagnosed with cancer given alive and cancer-free at current age, 2007-2009.
        (Available at:) (Accessed August 25, 2018)
        • U.S. Life Tables, 2014
        National Vital Statistics Reports; 66(4). August 14, 2017.
        (Available at:)
        • Siegel R.
        • DeSantis C.
        • Jemal A.
        Colorectal cancer statistics, 2014.
        CA Cancer J Clin. 2014; 64: 104-117
        • Lee J.K.
        • Jensen C.D.
        • Levin T.R.
        • et al.
        Long-term risk of colorectal cancer and related deaths after a colonoscopy with normal findings.
        JAMA Intern Med. 2019; 179: 153-160
        • Klabunde C.N.C.K.
        • Breen N.
        • Waldron W.R.
        • et al.
        Trends of colorectal cancer test use among vulnerable populations in the US.
        Cancer Epidemiol Biomark Prevent. 2011; 20: 1611-1621
        • Imperiale T.F.
        • Glowinski E.A.
        • Lin-Cooper C.
        • et al.
        Five-year risk of colorectal neoplasia after negative screening colonoscopy.
        N Engl J Med. 2008; 359: 1218-1224
        • Siegel R.L.
        Colorectal cancer statistics, 2014.
        CA Cancer J Clin. 2014; 64: 104-117